OncologyLive® is the flagship publication of OncLive®. Each issue delivers expert insights and clinical oncology news and updates, which impact the day-to-day clinical practice of oncology professionals who work tirelessly to help improve patient outcomes.

Following the passage of the Health Information Technology for Economic and Clinical Health Act (HITECH) of 2009, electronic health records (EHRs) were rapidly adopted by health systems across the United States.

 Based on reports published in 2019, 89.9% of office-based physicians use EHR systems.

 EHRs have the potential to improve quality of care and patient outcomes.

 EHR adoption has clear benefits, such as facilitating access to past medical records, making order placement easier, and improving communication with other health care providers. However, EHR systems’ design, usability, and interoperability issues can hinder integration and use.

As a practical first step in EHR integration, paper reports were converted to digital copies. This improved accessibility and eliminated the need for storing hard copies of these documents in conventional hospital archives.

 However, these files were stored as digital images, which, at best, could be converted to plain text. Following this path, providers started typing or using transcription services to generate progress notes and most other reports. Unfortunately, this approach drastically limits the potential advantages and applications of EHRs.

Despite improvements in order entry, most of the results, except for laboratory tests with discrete data, were entered into the EHR as plain text reports. Some of these reports (eg, pathology and genetic testing) still are generated from discrete data elements initially recorded in another database. This trend created a large number of reports that were better organized and more accessible but only comprehensible to human users because the computers running the EHR do not understand English.

One of the primary functions of EHR platforms is to facilitate human-machine interactions by translating our phrases into code (machines’ language). For example, malignant diagnosis and disease stage might be clearly documented in an oncology office visit note. However, this information is not accessible to the EHR unless it is converted to numbers, such as 

 codes, and stored in a prespecified location in the EHR, such as the list of current medical problems. Further, entering the diagnosis into the problem list requires additional steps to open that section of the EHR, find the accurate diagnosis with necessary relevant details, and enter cancer staging information.

In addition to interacting with the patient to gather information and perform a physical examination, generating a report (eg, consult notes or progress notes) might be the focus of the clinicians’ routine workflow. These reports are the primary method of communication with other care team members and are commonly used to support billing. Documentation styles and preferences are highly variable among clinicians. They might use dictation transcription services, voice recognition technologies, note templates and macros, or free text to generate reports. Although most providers acknowledge the value of discrete data availability in EHR, many consider the required additional steps for data entry at the point of care highly disruptive to their clinical workflow and a barrier to practicing medicine a way that is most effective.

Let us return to our example of malignant diagnosis. Finding the accurate diagnosis and relevant details in an unstructured note can be challenging. Reviewing multiple prior reports might be necessary, which will increase the review time and the reader’s cognitive burden. Adding diagnosis to the problem list will make it easier for other care team members to retrieve this information. In addition, the discrete data can support secondary clinical use, such as integration of clinical decision support tools and pathways, clinical trial recommendations, and billing.

Multiple factors, including EHR design, inadequate training, and insufficient appointment time augment the challenge of discrete data collection at the point of care. Artificial intelligence and natural language processing platforms may help identify and extract clinically relevant information from our notes or conversations with patients during a visit. In the interim, we should focus on improving our EHR design and developing user-friendly tools that are least disruptive to clinical workflows.

It is imperative to engage clinicians as early as possible in designing any new informatics tool. Discussing the need for change, the selected approach’s rationale, and the outcome’s potential effect on the practice can lead to easier product integration in the established workflows and improve user adherence. Applying these principles, the University of Wisconsin Carbone Cancer Center team implemented an automatic validation step when closing the encounter, improving the capture of discrete data on malignant diagnosis and staging.

 Learning from the routine clinical workflows, we have embedded data collection forms in our standardized note templates.

These forms integrate collection of discrete data related to disease and treatment into the process of writing a note. The collected data serve multiple purposes. They generate parts of the disease assessment and treatment response evaluation in the progress notes and support rule-based EHR functions such as clinical decision support tools and clinical trial recommendations. In addition, this information is displayed in a longitudinal reporting dashboard to facilitate a comprehensive review of the disease course at a glance. Discrete data are the key to realizing EHR’s full potential.

Hamid Emamekhoo, MD, is an assistant professor and faculty member in the Department of Medicine, Division of Hematology, Medical Oncology, and Palliative Care at the University of Wisconsin School of Medicine and Public Health in Madison. He is also a member of the University of Wisconsin Carbone Cancer Center.

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Diaz-Garelli F, Strowd R, Ahmed T, et al. What oncologists want: identifying challenges and preferences on diagnosis data entry to reduce EHR-induced burden and improve clinical data quality. 

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Articles

Electronic health record systems’ design, usability, and interoperability issues can hinder integration and use.

Discrete Data Are Key to Realizing Electronic Health Records’ Full Potential

The frontline treatment for patients with head and neck cancer is largely dominated by surgery and radiation therapy, with ongoing efforts to find biomarkers and other strategies to better individualize care. The leading markers used to tailor therapy are human papillomavirus (HPV) status, which typically signals the aggressiveness of the disease, and PD-L1 expression level, which may help guide selection of immune checkpoint inhibitor (ICI) therapy.

These markers are gaining notice in different settings. HPV status has broad applicability across head and neck cancers, whereas the clinical utility of PD-L1 expression remains a more nuanced question.

Approximately 70% of head and neck cancers, specifically oropharyngeal cancers, are positive for HPV, with most cases associated with the HPV-16 subtype. These tumors appear most commonly in nonsmoking White men with a mean age of diagnosis of 60.3 years (SD, 10.8) for oropharyngeal cancer and 63.2 years (SD, 12.7) for other types of head and neck cancers.

Moreover, HPV-positive tumors typically fall into a low- to intermediate-risk category, with 5-year overall survival (OS) outcomes far superior compared with rates for HPV-negative tumors, which are typically caused by smoking. For patients with HPV-associated head and neck cancers, the 5-year OS rate ranges from 75% to 80% compared with 45% to 50% for those with HPV-negative tumors.

In many cases, although the prognosis is more favorable for patients with HPV-positive tumors, the treatment is the same as it is for HPV-negative tumors. However, with the introduction of ICIs and other options, deintensified treatment regimens are being explored for patients with head and neck cancer, based on their HPV status coupled with clinical characteristics.

“We really want to cure these patients. These are young patients who are otherwise healthy who have decades of life. Even an incremental decrease in the outcome of survival is a concern, but we’re balancing that with the toxicity of the therapies,” Glenn J. Hanna, MD, said during a presentation at the 

: Innovative Cancer Therapy for Tomorrow in November 2022. He is director of the Center for Salivary and Rare Head and Neck Cancers at Dana-Farber Cancer Institute and an assistant professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

Risk-Adapted Therapy for HPV-Positive Tumors

Several studies are assessing a reduced radiation dose for patients with HPV-positive head and neck cancer. The standard radiation dose for locoregionally advanced head and neck cancer is 70 Gy, which Hanna mentioned is one of the highest in all of oncology, warranting deintensification to avoid morbidity. Across these studies, clinical characteristics are being used to further classify risk for those with HPV-positive disease, such as tumor size, margins following surgery, extracapsular spread (ECS), and lymph node involvement.

The phase 2 NRG-HN002 study (NCT02254278)

 specifically examined a 60-Gy intensity-modulated radiation therapy (IMRT) dose either alone or with cisplatin. The 2-year progression-free survival (PFS) rate for patients who received IMRT plus cisplatin was 90.5% (90% lower confidence bound [LCB], 86.6%; 

 = .04), which met the primary end point for the trial, compared with 87.6% (90% LCB, 83.3%; 

 = .23) with IMRT alone. The MD Anderson Dysphagia Inventory mean score for the combination was 85.3 at 1 year, representing a significant improvement, Hanna said.

The NRG-HN005 study (NCT03952585) is exploring other combinations for patients with HPV-positive oropharyngeal squamous cell carcinoma, including 60 Gy with cisplatin or nivolumab (Opdivo), a PD-1 inhibitor. This phase 2/3 study is recruiting participants.

Other combination partners have been tested with radiation therapy, with varying results for patients with HPV-positive head and neck cancer. In the De-ESCALaTE HPV study (NCT01874171), the combination of 70 Gy of IMRT plus cetuximab (Erbitux) was inferior to cisplatin plus 70 Gy.

 Although this study did not show a superior partner to traditional platinum chemotherapy, other studies looking at induction chemotherapy followed by concurrent chemotherapy with low-dose radiation did show promise.

 patients with HPV-positive cancers who experienced a complete response to induction therapy with cisplatin, paclitaxel, and cetuximab received low-dose IMRT at 54 Gy in 27 fractions plus weekly cetuximab. The 2-year OS with this approach was 94% (95% CI, 82%-98%). Moreover, quality-of-life improvements were noted, with fewer swallowing issues and less nutrition impairment than expected, Hanna said.

A similar approach with nab-paclitaxel (Abraxane) incorporated into the induction phase along with carboplatin was explored in the phase 2 OPTIMA study (NCT02258659).

 In this study, response to induction and clinical risk were used to tailor subsequent therapy. Patients with a low risk received 50 Gy of radiation therapy alone, whereas participants with intermediate to high risk received standard-dosed chemoradiotherapy. Overall, findings showed that the 2-year OS rate was 100% among patients with low-risk disease and 97% for those with high-risk disease.

The subsequent OPTIMA II study (NCT03107182) moved this induction regimen to the locoregional setting with the addition of nivolumab to nab-paclitaxel and carboplatin.

 Findings showed the 2-year OS with the triplet induction followed by 50 Gy of radiation or surgery was 96.0% in the low-risk group, defined as those with postinduction shrinkage of 50% or more. The 2-year OS was 91.9% for the low-risk/ lower-response and high-risk/high-response group and 100.0% for an all-others high-risk group, which both received standard chemoradiotherapy after triplet induction.

“The concept is that people are trying to use lower-dose IO [immuno-oncology], radiation, or chemotherapy up front to select a patient for less radiation in the back,” said Hanna.

As with every successful strategy, the goal is to move a novel regimen earlier in the treatment paradigm. In the E3311 study (NCT01898494), risk stratification was moved into the adjuvant setting by applying it directly following transoral resection for patients with HPV-positive tumors. In this study, participants with T1-T2 N0-N1 tumors with negative margins were eligible for observation following surgery, whereas those with higher-risk disease received riskadapted treatments.

 the 2-year PFS was 96.9% (90% CI, 91.9%-100%) for patients in the low-risk observation group after primary transoral surgery. Those with intermediate-risk disease (clear/close margins, < 1 mm ECS, 2-4 metastatic nodes) after surgery received either 50 Gy in 25 fractions or 60 Gy in 30 fractions, with similar outcomes: 2-year PFS rates of 94.9% (90% CI, 91.3%-98.6%) and 96.0% (90% CI, 92.8%-99.3%), respectively. Patients with high-risk disease (positive margins, > 1 mm ECS, ≥ 5 metastatic lymph nodes) received 66-Gy/33-fraction radiotherapy with cisplatin and had a 2-year PFS of 90.7% (90% CI, 86.2%-95.4%).

“Promising strategies exist, but where do you start?” asked Hanna. “Everyone is doing their own thing: less radiation, minimizing chemotherapy, using immunotherapy, selecting based on surgery, plasma HPV DNA. Stratification is really going to rely on biomarker selection being integrated into decision-making.”

Role of PD-L1 Expression in Head and Neck Cancer

National Comprehensive Cancer Network guidelines for head and neck cancer place the ICIs nivolumab and pembrolizumab (Keytruda) as category 1 preferred options for patients with recurrent, unresectable, or metastatic head and neck squamous cell carcinoma (HNSCC).

 However, these guidelines also note that the role and definition of PD-L1 expression remain ambiguous, with only an association seen between positive expression and better outcomes.

“We all know that PD-L1 expression is important in management of the disease. It was originally established with just basic immunohistochemistry that some squamous cell carcinomas do express PD-L1. Now, we have a little bit more clarity on how to quantify this in head and neck cancer,” Ranee Mehra, MD, said during a presentation at the 

 conference. Mehra is director of head and neck medical oncology and a professor of medicine at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center in Baltimore, Maryland.

Clinical trials exploring immunotherapies in head and neck cancer have used 2 different definitions for PD-L1 positivity. The first, tumor proportion score (TPS), uses the percentage of tumor cells with PD-L1 expression on the membrane. The other measure, combined positive score (CPS), is the amount of PD-L1 expressed on immune cells divided by the number of tumor cells, with the final number then multiplied by 100. In both cases, the scores range from 0 to 100 and a score of 1 or greater indicates the cell is PD-L1 positive.

“The TPS score is used primarily in non–small cell lung cancer,” noted Mehra. “In head and neck cancer, we use CPS.”

The optimal method for measuring PD-L1 expression in head and neck cancer was established early in the development of ICIs for these cancer types, Mehra said. She described findings from the phase 1B KEYNOTE-012 study (NCT01848834) of pembrolizumab monotherapy in separate cohorts of patients with advanced solid tumors, including patients with recurrent/ metastatic HNSCC (

PD-L1 expression was examined by TPS and CPS in 188 patients with HNSCC. By the TPS measure, those with PD-L1–positive expression (n = 123) had an objective response rate (ORR) of 18% (95% CI, 12%-26%). Those whose tumors were PD-L1 negative by TPS (n = 65) had an ORR of 19% (95% CI, 10%-30%), providing little additional value for testing. By CPS, however, those with PD-L1–positive disease (n = 152) had an ORR of 21% (95% CI, 15%-28%), whereas those with PD-L1–negative expression (n = 36) had an ORR of 6% (95% CI, 1%-19%), suggesting a correlation with response.

Although such findings are informative, responses to PD-1 inhibitors have been noted even in the absence of PD-L1 expression. Further, most studies have included patients with both positive and negative expression, with minor differences seen between the intention-to-treat (ITT) populations and PD-L1–based subsets in large phase 3 trials.

As an example, Mehra discussed the phase 3 KEYNOTE-048 study (NCT02358031), in which pembrolizumab was explored with or without the addition of platinum-based chemotherapy and 5-fluorouracil (5-FU) for patients with recurrent or metastatic head and neck cancer.

In 5-year findings from the study, which were presented at the European Society for Medical Oncology Congress 2022 in September (ESMO 2022),

 there was an improvement in OS seen with both pembrolizumab monotherapy and the combination of pembrolizumab and chemotherapy when compared with the EXTREME chemotherapy regimen alone, which comprises cetuximab, 5-FU, and platinum-based chemotherapy.

In the ITT population, the 5-year OS rate was 14.4% and 16.0% with pembrolizumab monotherapy and combination therapy, respectively, vs 6.5% and 5.2% with the EXTREME regimen.

In patients with a PD-L1 expression of 1 or more by CPS, the median OS with single-agent pembrolizumab was 12.3 months (95% CI, 10.814.8) compared with 10.4 months (95% CI, 9.0-11.7) for EXTREME (HR, 0.74; 95% CI, 0.610.89). Median OS was 13.6 months (95% CI, 10.7-15.5) for the combination of pembrolizumab and chemotherapy compared with 10.6 months (95% CI, 9.1-11.7) for EXTREME (HR, 0.65; 95% CI, 0.53-0.79). For those with a CPS of 20 or more, the benefit for the addition of the PD-1 inhibitor was more pronounced, with HRs of 0.61 (95% CI, 0.460.81) and 0.63 (95% CI, 0.47-0.84) for the single agent and combination vs EXTREME, respectively.

“Pembrolizumab was favored over EXTREME chemotherapy, in the intention-to-treat population and in the CPS greater than or equal to 1 population,” said Mehra. “It is gratifying to see survival data where we’re seeing survivals approaching 15% in 5 years for recurrent and metastatic head and neck cancer, which was previously unheard [of] in the era before immunotherapy.”

In a separate assessment of PD-L1 expression from KEYNOTE-048,

 patients with PD-L1 CPS expression of less than 1 had better outcomes with the EXTREME regimen compared with pembrolizumab. In those with PD-L1 CPS less than 1, the 12-month OS rate was 49% with EXTREME compared with 39% with single-agent pembrolizumab (HR, 1.51; 95% CI, 0.96-2.37; 

 = .96241). Moreover, in this same population, the 12-month OS was 47% with EXTREME compared with 41% with pembrolizumab plus chemotherapy (HR, 1.21; 95% CI, 0.761.94; 

At PD-L1 CPS ranges of 1 to 19, the PD-1 inhibitor regimen began to emerge as a better option vs chemotherapy. For pembrolizumab monotherapy, the 12-month OS rate was 44% (95% CI, 35.1%-52.5%) vs 42.4% (95% CI, 33.9%-50.7%) with EXTREME, although this was not statistically significant (HR, 0.86; 95% CI, 0.66-1.12; 

 = .12827). For the combination of pembrolizumab plus chemotherapy, the 12-month OS rate was 52.6% (95% CI, 43.1%-61.2%) in those with a CPS of 1 to 19 vs 41.1% (95% CI, 32.4%-49.6%) with EXTREME (HR, 0.71; 95% CI, 0.540.94; 

“This was a subset analysis, and we still have the [ITT] population analysis, which showed the benefit of pembrolizumab monotherapy in PD-L1 expressers of greater than 1,” said Mehra. “I think there still is a role for using the KEYNOTE-048 regimens, but it is important to still utilize the CPS data to paint a full picture and to determine for an individual patient what type of regimen might be better.”

After showing initial success in the recurrent/metastatic setting, the investigation of pembrolizumab is beginning to move into earlier settings. For those with newly diagnosed locally advanced HNSCC, the KEYNOTE-412 study (NCT03040999) examined pembrolizumab with standard chemoradiation vs placebo plus chemoradiation, with findings presented at ESMO 2022.

In the ITT population of KEYNOTE-412, the 36-month event-free survival (EFS) rate was 57.4% with pembrolizumab compared with 52.1% with chemoradiotherapy alone, which did not meet the threshold for statistical significance (HR, 0.83; 95% 0.68-1.03; 

In subgroup analyses for EFS looking at PD-L1 expression by CPS, the HR was 1.09 (95% CI, 0.56-2.11) in patients whose tumors had a CPS of less than 1; however, it was 0.80 (95% CI, 0.641.00) favoring pembrolizumab with a CPS of 1 or more. In those with PD-L1 expression by CPS of 20 or more, the 36-month EFS was 66.7% with pembrolizumab/chemoradiation compared with 57.2% for chemoradiation alone; however, this did not reach statistical significance (HR, 0.73; 95% CI, 0.49-1.06).

The CPS subset analysis was more hypothesis generating, Mehra said. Moreover, she added that other studies have shown similar disappointing findings when combining immunotherapy with chemoradiotherapy, including those with the PD-L1 inhibitors avelumab (Bavencio) and durvalumab (Imfinzi).

“We have a few randomized trials now that are raising questions on how to incorporate immunotherapy with radiation,” she said. “Immunotherapy is not a radiation sensitizer. It does not have the DNA-damaging effects that cisplatin does. We have to stop thinking of it as a radiation sensitizer.”

In addition to HPV and PD-L1, indicators are emerging that could further risk-stratify therapy for patients with head and neck cancer. Epigenetic markers are under exploration, with some gene methylation patterns effectively predicting recurrence; however, these approaches are not ready for prime time, Hanna said.

A key imaging approach under exploration involves a tumor hypoxia assessment (FMISO). In the 30 ROC trial (NCT00606294) exploring this approach,

 tumors were resected and then a hypoxia assessment was completed using PET or CT scan and 18F-FMISO PET. Patients whose tumors were positive for hypoxia received standard 70-Gy radiotherapy plus cisplatin and those testing negative for hypoxia received 30 Gy of radiation plus cisplatin. This hypoxia measure was combined with HPV circulating plasma cell-free DNA (cfDNA) analysis to further predict risk.

Those in the low-risk group by cfDNA but with any type of clinical risk who had no hypoxia had a 2-year locoregional control rate of 94.4% (95% CI, 84.4%-100.0%) and a 2-year OS rate of 94.7% (95% CI, 85.2%-100.0%). Whole genome sequencing was also completed on the resected tumors, with detected DNA repair defects associated with response (

“This is more than a 50% reduction in radiation,” said Hanna. “This is really exciting, and it is pushing the limits of how low you can really go with radiation doses.”

Another biomarker-based strategy on the horizon for risk-stratifying therapy involves the quantification of circulating tumor tissue-modified viral (TTMV) HPV DNA. When used as a method for posttreatment surveillance, TTMVHPV DNA had a positive predictive value of greater than 95% in a chart review involving data from 1076 patients.

 Additionally, the negative predictive value for TTMV-HPV DNA was also found to be 95%.

“HPV cancers have HPV virus in the tissue; it shouldn’t be anywhere else. If you have a tumor, and it sheds that virus at some rate, it is detectable in the blood. If I kill your cancer, I shouldn’t detect it in the blood,” Hanna said. “This is really transforming how we are thinking about HPV disease.”

Further work was completed to quantify the level of circulating tumor HPV DNA (ctHPVDNA), with the levels before and after treatment found to be informative of recurrence risk.

 Patients with a high baseline level of plasma ctHPV16DNA (> 200 copies/mL) that was reduced by 95% or more at day 28 post treatment with chemoradiation were found to have far superior outcomes, regardless of their clinical risk, compared with those with an unfavorable ctHPV16DNA clearance profile. Among patients with a favorable clearance profile, the regional disease-free survival (DFS) rate at 24 months was 100%. Those with poor clinical features and unfavorable ctHPV16DNA clearance had a 24-month DFS rate of 65%.

“I think the ctDNA is a great approach to get early signs of activity and response, especially for those more intermediate PD-L1 levels,” said Mehra. “I think incorporating imaging, how [patients are] tolerating treatment, and ctDNA are all great approaches.”

The TTMV-HPV DNA profile furthest along in development, known as NavDx, is being investigated as a means for risk-adapting therapy for patients with HPV-positive oropharyngeal cancer in the phase 2 ReACT study (NCT04900623). In ReACT , patients with intermediate clinical risk (T4, N0-2 and/or > 10 pack-year smoking history) will be stratified based on their ctHPVDNA clearance status following surgery. Those with a favorable risk by TTMV-HPV DNA clearance will receive a reduced dose of IMRT with or without low-dose cisplatin; those with unfavorable risk by ctHPVDNA will receive standard IMRT at 70 Gy plus cisplatin. The trial is recruiting participants.

There are various potential uses for a marker such as TTMV-HPV DNA, noted Hanna. “I actually use HPV DNA as a mechanism to monitor HPV-positive metastatic patients,” he said. “If they clear their DNA or I see the values are decreasing, I will feel more comfortable with an abbreviated PD-1 time course.”

The next step for personalized head and neck cancer treatment relies on a combination of strategies, Mehra noted. Several agents in the pipeline specifically target HPV, with the most promising being PDS0101, a T-cell–activating therapy specific to HPV, and CUE-101, a fusion protein designed to selectively deliver IL-2 to HPV-specific T cells.

Findings for both agents were presented at the 2022 American Society of Clinical Oncology Annual Meeting in June.

 For PDS0101 combined with pembrolizumab, the ORR was 41.2% in 17 patients with HPV-positive recurrent or metastatic HNSCC in the phase 2 VERSATILE-002 study (NCT04260126). The disease control rate with the combination was 76.5%. For CUE-101 plus pembrolizumab, the ORR was 28.6% among 7 evaluable patients with a disease control rate of 57.1% in a first-in-human study (NCT03978689). Both agents have received fast track designations from the FDA for head and neck cancer in combination with pembrolizumab. The designation for CUE-101 also covers its use as monotherapy.

“These are things to watch for in the future, as ways to enhance immunotherapy response, at least for HPV-positive disease,” said Mehra.

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PDS Biotechnology granted FDA fast track designation for lead candidate PDS0101. News release. PDS Biotechnology Corporation. June 2, 2022. Accessed November 15, 2022. https://bit.ly/39beCu4

Cue Biopharma granted FDA fast track designation for CUE-101 for the treatment of recurrent/metastatic head and neck squamous cell carcinoma. News release. Cue Biopharma. October 4, 2022. Accessed November 15, 2022. https://bit.ly/3SCsChQ

HPV status has broad applicability across head and neck cancers, whereas the clinical utility of PD-L1 expression remains a more nuanced question.

HPV, PD-L1 Move to the Forefront of Biomarkers for Head and Neck Cancers

Data concerning the long-term benefit of PARP inhibitors as maintenance therapy for select patients with ovarian cancer in later-line settings have come under fire in 2022 as several agents have failed to demonstrate improvements in overall survival (OS) outcomes.

These data readouts have resulted in recommendations from the FDA, the Oncology Drug Advisory Committee (ODAC), and the drug sponsors for the removal of indications for rucaparib (Rubraca), niraparib (Zejula), and olaparib (Lynparza) in heavily pretreated patients with BRCA-mutant ovarian cancer.

The removal of indications is only one of the stories being told in ovarian cancer this past year. In a recent OncLive Peer Exchange®, an expert panel of gynecologic oncologists highlighted areas of ongoing research that have demonstrated improvements for frontline maintenance therapies as well as advances in the novel agents for patients with recurrent disease. 

“It was easier when it was just carboplatin and paclitaxel, now we have a lot of choices with these active drugs,” Michael J. Birrer, MD, PhD, said. “Stratifying patients more carefully with biomarkers is going to be important, [as well as] working work with our regulatory [partners] to get a consensus on OS vs [progression-free survival] PFS because the field of ovarian cancer is now moving toward [where] non–small cell lung cancer is [in terms of using outcomes], and we need to have the same sort of agreement on how we’re going to go forward [with data to support indications]. One of the ways we could effectively do that is to point out that we can stratify our patients better, for example with homologous recombination deficiency [HRD] testing.”

The voluntary withdrawal of indications for heavily pretreated patients with BRCA-mutated ovarian cancer stem from OS data reflecting HRs that failed to demonstrate a benefit with prolonged PARP inhibitor therapy in this patient population.

 The manufacturers of niraparib, olaparib, and rucaparib each issued statements that the data no longer support the use of these agents. “[What happens with] these dear doctor letters is the sponsor says we looked at the data, we had conversations with the FDA, we decided to withdraw this accelerated approval for whatever reason, right or wrong,” Bradley J. Monk, MD, said.

The voluntary withdrawal of indications began in June 2022, when Clovis removed the indication for rucaparib for patients with BRCA-mutated ovarian cancer after at least 2 prior chemotherapies in the United States and Europe. The FDA granted accelerated approval to the PARP inhibitor in December 2016 for the treatment of patients with deleterious BRCA mutation (germline and/or somatic)–associated advanced ovarian cancer following 2 or more chemotherapies. In 2 open-label, single-arm trials, investigator- assessed ORR was 54% with a median duration of response of 9.2 months.

In November 2022, the FDA issued a notice to Clovis requesting that the company limit the use of rucaparib to second-line maintenance therapy for patients with recurrent ovarian cancer harboring BRCA mutations. If the 2 sides cannot reach an agreement on the revised indication, the FDA said it would convene an ODAC meeting to review the matter. 

In August 2022, AstraZeneca and Merck notified providers that olaparib was no longer indicated for adults with BRCA-mutated advanced ovarian cancer who have received at least 3 prior lines of chemotherapy following a safety analysis of the phase 3 SOLO3 trial (NCT02282020). At a median follow-up of 48.9 months in patients who received 2 or more lines of prior chemotherapy, olaparib monotherapy elicited a median OS of 34.9 months. At a median follow-up of 25.4 months, patients who were administered chemotherapy experienced a median OS of 32.9 months (HR, 1.07; 95% CI, 0.76-1.49).

In an evaluation of patients who received at least 2 lines of therapy, 65.2% of those who received olaparib died by the April 2021 data cutoff compared with 52.3% of those assigned to chemotherapy. For patients who received 3 or more prior lines of chemotherapy, 70.0% of patients in the olaparib arm had died compared with 54.8% of those assigned to chemotherapy.

Finally, niraparib was indicated for use with patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with 3 or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)–positive status.6 In September 2022, GSK notified providers that investigators identified “a potential detrimental effect” on OS in patients treated with other PARP inhibitors in trials evaluating niraparib as third-line or later therapy for patients with BRCAmutated advanced ovarian cancer. 

The review of the indication was scheduled to undergo review by ODAC considering the release of survival data from the phase 3 NOVA study (NCT01847274); however, the meeting was cancelled in October 2022 after the agency cited that the meeting was no longer needed.

 In September 2022, the indication for the treatment of patients with HRD-positive ovarian cancer after 3 or more prior lines of chemotherapy was removed.3 The data from the NOVA study will be presented during a plenary session from the European Society for Medical Oncology (ESMO).

 In November 2022, the manufacturer restricted use of the agent as a secondline maintenance strategy to only patients with deleterious or suspected deleterious germline BRCA mutations. The frontline maintenance indication remained unchanged.

“This [decision] harks back to the infectious nature of this dear doctor stuff,” Birrer said. “In this case, to a certain extent, the sponsor is seeing a very shrinking market for these agents because the median [lines of prior therapy in the studies] is 4 lines or more, every [patient] is getting PARP [inhibition] upfront and that’s good. [Related] to that is the concern about these preliminary OS interpretations with HRs and CIs extended over 1. The general [precedent] is not a good one [and] some work needs to be done to educate both the community oncologists and then also we need discussions with the FDA.”

What appeared to be an emerging trend for these agents in this population was a concern for Monk. “We’re advocates for patients,” Monk said. “In our everyday practice we have seen patients who for whatever reason haven’t seen a PARP inhibitor [as a] later line of therapy, where chemotherapy in my experience is not very effective…. These randomized trials put that [choice] into question—[outcomes showed] the PARP inhibitors improves response rates, they improved progression-free survival [PFS]. The influence on OS is maybe in settings that are not relevant to my practice pattern.”

“The science has been around since 2018 and we also have data from 2012 saying that there is a strong relationship between BRCA mutation and the expectation for treatment to PARP,” Robert L. Coleman, MD, FACOG, FACS, said, adding that there is confidence using PARP maintenance in the frontline setting.

“The unified [opinion] is that every patient with a BRCA mutation and newly diagnosed advanced ovarian cancer that responds to platinum needs a PARP inhibitor,” Monk said. “I’m less passionate about which PARP inhibitor.”

Two years of olaparib maintenance therapy elicited a long-term OS benefit vs placebo in patients with newly diagnosed, advanced ovarian cancer harboring a BRCA mutation, according to 7-year follow-up f indings from the phase 3 SOLO1/GOG-3004 trial (NCT01844986) presented at the 2022 ESMO Congress and simultaneously published in the Journal of Clinical Oncology.

“We are really familiar with SOLO1, in which patients are treated up front: They had their primary platinum treatment and a benefit of some kind and were randomly assigned between olaparib for 2 years or placebo,” Shannon N. Westin, MD, MPH, FACOG, said. “We’ve seen presentations of the PFS data which have remained very solid at an HR of 0.33 so these patients are living longer without progression.” 

As of the data cutoff of March 7, 2022, the median OS was not reached with olaparib compared with 75.2 months with placebo (HR, 0.55; 95% CI, 0.40-0.76; P = .0004). The 7-year OS rates were 67.0% in the olaparib arm and 46.5% in the placebo arm. The median duration of follow-up in the olaparib and placebo arms was 88.9 months (range, 85.7-93.6) and 87.4 months (range, 84.391.7), respectively.

At data cutoff, 45.3% of patients in the olaparib arm and 20.6% in the placebo arm had still not received a first subsequent treatment, while 44.3% of patients given placebo received a PARP inhibitor in a subsequent line of therapy, compared with 14.6% of patients in the olaparib group. 

“What’s always been really exciting about the PFS and now the OS curves is that we anticipated that the patients with BRCA mutations do the best and so we thought maybe the control arm would perform better,” Westin said, adding that these patients are younger and healthier and typically respond better to treatment. “That’s not what we’re seeing. We are seeing consistent benef it in that patient population with the use of the PARP inhibitor.”

No new safety signals were observed during the 7-year follow-up. The incidence of myelodysplastic syndrome/acute myeloid leukemia remained low in the olaparib and placebo arms (1.5% vs 0.8%, respectively) and new primary malignancies remained balanced between arms (5.4% vs 6.2%). Pneumonitis occurred in 5 patients treated with olaparib.

A combination of bevacizumab (Avastin) and olaparib was evaluated as a frontline treatment for patients with ovarian cancer who had a response to chemotherapy and no evidence of disease remaining in the phase 3 PAOLA-1/ ENGOT-ov25 trial (NCT02477644). At the ESMO Congress 2022, data from the final OS analysis showed a clinically meaningful improvement after a median follow-up of 61.7 months (range, 57.5-67.0) in the olaparib arm and 61.9 months (range, 58.1-66.8) in the placebo arm. The median OS in the intention-to-treat (ITT) population was 56.5 months vs 51.6 months, respectively (HR, 0.92; 95% CI, 0.76-1.12; P = .4118). Moreover, OS rates at 5 years were 47.3% with the addition of olaparib compared with 41.5% with placebo.

In patients with tumors positive for HRD, the addition of olaparib to bevacizumab maintenance therapy reduced the risk for death by 38% (HR, 0.62; 95% CI, 0.45-0.85), with 5-year OS rates of 65.5% with the combination regimen and 48.4% with placebo. This benefit was consistent across patients who harbored a BRCA mutation (5-year OS rates, 73.2% vs 53.8%, respectively; HR, 0.60; 95% CI, 0.39-0.93) and those who did not (5-year OS rates, 54.7% vs 44.2%; HR, 0.71; 95% CI, 0.45-1.13). However, no benefit was seen in HRD-negative patients (5-year OS rates, 32.3% vs 25.7%, respectively; HR, 1.19; 95% CI, 0.88-1.63).

“It’s difficult to really call [bevacizumab alone a] control arm,” Birrer noted in a discussion of the trial design. “In some regard that explains the results, which are that there was a statistically significant OS prolongation in the HRD population, which included BRCA or no BRCA mutation. If you look at the ITT [data], it has an HR of 0.92, which is not statistically significant. In the HRD population it certainly was, with an HR of 0.62. Very impressive.” 

Westin noted that even though more clinicians are using bevacizumab now, “it took a long time to get there. We’re seeing more bevacizumab use in the community.” Considering that, data from longer follow-up are emerging to that may influence treatment schemas for maintenance therapy. A recent study published in the 

 signaled that bevacizumab beyond 15 months did not improve PFS in patients with newly diagnosed stage IIB to IV ovarian cancer.

Data from the phase 3 BOOST trial (NCT01462890) showed that among 2 cohorts of patients with ovarian cancer receiving bevacizumab, there was no difference in PFS between the treatment arms (HR, 0.99; 95% CI, 0.851.15; P = .90). The median PFS with 15 months of treatment was 24.2 (95% CI, 22.2-26.5), and extended treatment of 30 months yielded a median PFS of 26.0 months (95% CI, 23.7-29.7). OS outcomes were also similar between the 2 arms (HR, 1.04; 95% CI, 0.87-1.23; P = .68).

Monk noted that the update from the phase 3 PRIMA trial (ENGOT-OV26/GOG-3012; NCT02655016) is the pivotal trial supporting the argument for HRD testing. In the latest results, maintenance treatment with niraparib produced a sustained and durable PFS benefit in patients with primary advanced ovarian cancer who responded to first-line platinum-based chemotherapy, spanning biomarker subgroups.

At a median follow-up of 3.5 years, the median PFS with niraparib was 24.5 months per investigator assessment vs 11.2 months with placebo in the HRD population (n = 373; HR, 0.52; 95% CI, 0.40-0.68; P < .001). In the overall population (n = 733), the median investigator-assessed PFS with niraparib was 13.8 months vs 8.2 months with placebo (HR, 0.66; 95% CI, 0.56-0.79; P < .001).

 Treatment with niraparib boosted the duration of PFS vs placebo across the biomarker subgroups examined. The greatest benefit was observed in those with HRD tumors that were BRCA mutated (HR, 0.45; 95% CI, 0.32-0.64). 

“It was nice to see that the curves [with longer-follow up] are parallel. They continued to parallel out with over 3 years. It’s confirmation across analytical end points providing more confidence that [niraparib] works in those with biomarker-positive mutations,” Coleman said.

Rucaparib maintenance therapy improved PFS vs placebo in patients with newly diagnosed ovarian cancer, according to disease risk subgroup analyses from the phase 3 ATHENA–MONO study (NCT03522246).

Among patients with HRD, the median PFS was 28.7 months with rucaparib vs 11.3 months with placebo (HR, 0.47; 95% CI, 0.31-0.72; log-rank P = .0004). In the overall population, the median PFS was 20.2 months vs 9.2 months, respectively (HR, 0.52; 95% CI, 0.40-0.68; log-rank P < .0001). Notably, the 24-month PFS rate in the ITT population was 45.1% vs 25.4% for rucaparib and placebo, respectively. The benefit of rucaparib was consistent across subgroups.

PFS was also assessed in terms of response to first-line chemotherapy. Among patients who achieved a partial response, the median PFS was 14.8 months (95% CI, 9.1-25.6) and 9.1 months (95% CI, 3.5-9.2; HR, 0.43; 95% CI, 0.18-1.02) in the HRD population and 12.2 months (95% CI, 9.2-19.7) and 6.4 months (95% CI, 3.7-9.2) in the ITT population following treatment with rucaparib and placebo, respectively. Among complete responders (CRs), the median PFS was 25.8 months (95% CI, 17.4-not reached [NR]) and NR (95% CI, 2.5-NR) in the HRD population following treatment with rucaparib and placebo, respectively. In the ITT population, the median PFS was 15.6 months (95% CI, 10.2-25.8) and 6.4 months (95% CI, 2.7-NR; HR, 0.48; 95% CI, 0.231.03), respectively. Safety was similar across patient subgroups.

“We have these 3 PARP inhibitors, olaparib, niraparib and rucaparib, [with the rucaparib data showing benefit] in the BRCA, HRD, and the HRD-negative subsets,” Monk said noting that rucaparib is not yet approved, but that applications to the FDA and European Medicines Agency are submitted.

Birrer, Westin, and Monk all agreed that testing becomes important for these patients. Monk noted, “You have to do 2 things to [take advantage of the PAOLA-1 opportunity: You [must give patients] bevacizumab and you must have molecular testing of the tumor [for HRD].” Coleman added, “As we get better with respect to [identifying and using] these biomarkers to guide treatment, patients are going to benefit and we’ll [know better which] patients shouldn’t [receive PARP maintenance]. I’m OK with the science continuing to move in that direction.” 

Oncology Live®

Data concerning the long-term benefit of PARP inhibitors as maintenance therapy for select patients with ovarian cancer in later-line settings have come under fire in 2022 as several agents have failed to demonstrate improvements in OS outcomes.

Treatment Complexities Continue  to Mount in Gynecologic Cancers

Clinical trials demand extreme rigor. A mistake in trial design, like a bookkeeping error, can lead regulators to reject a potentially valuable drug. Many researchers dislike this intense focus on dotting i’s and crossing t’s. Omid Hamid, MD, enjoys the challenge. 

“You have to do everything precisely. You have to be willing to have your clinic up for review. You have to continually be on your game,” Hamid said in an interview with 

Hamid’s enthusiasm for clinical trials and his expertise in conducting them have made him a world-renowned phase 1 immunotherapeutic researcher. His career has been defined through a significant role in testing most of the medications that have revolutionized the treatment landscape for patients with malignant melanoma since 2011, when the immune checkpoint inhibitor (ICI) ipilimumab (Yervoy) and the BRAF inhibitor vemurafenib (Zelboraf) gained their initial FDA approvals in advanced-disease settings.

For nearly 2 decades, Hamid has contributed to the advancements of the modern melanoma therapy era through his position as chief of Translational Research and Immuno-Oncology and director of Melanoma Therapeutics at The Angeles Clinic and Research Institute in Los Angeles, California. He also is a professor in the Department of Medicine and codirector of Cutaneous Malignancies at Cedars-Sinai Medical Center, which is affiliated with the institute.

Hamid will cochair the 19th Annual International Symposium on Melanoma and Other Cutaneous Malignancies

, which will take place February 4, 2023, in Irving, Texas. 

Hamid’s current duties combine clinical care and trial work on the experimental therapies that, he hopes, will continue to revolutionize the therapeutic landscape in melanoma. “If you’re successful, the drugs that bring patients into your clinical trials program become approved and available to all—which is phenomenal; it’s what you want,” Hamid said. “But it creates its own challenges. If you want to do more meaningful research, you need to work harder—look harder. 

“Approvals drive patients back into the community practices to get the treatments that have become standard,” he said. “If you want to attract patients for new trials, you need to be able to look for the next thing to test, the next thing that offers a real shot at improved outcomes. Finding those promising treatments takes time, effort, continual reading, continual working.”

Developing an Affinity for Oncology Practice

Before Hamid began the academic career that would take him to the highest rungs of melanoma research, his family embarked on its own momentous journey. Hamid was born in Iran, but his family fled the country when he was 6 years old, shortly after revolutionaries overthrew Shah Mohammad Reza Pahlavi in the late 1970s and established an Islamic republic.

 They moved to the United States and settled in Florida, where Hamid spent the rest of his childhood. 

Hamid headed west for high school and college, and aside from several years at the University of Iowa College of Medicine, he has stayed in California ever since, first as an undergraduate at UCLA and then as a medical student, intern, resident, and fellow at the University of Southern California’s Keck School of Medicine. 

When Hamid started medical school, he planned to become an independent pediatrician. He liked the idea of hanging out his shingle, running a clinic, and serving a community. He realized during rotations, however, that he preferred helping patients who faced serious illness and who were mature enough to express their feelings about it. 

“I don’t think there is any closer relationship in medicine than an oncologist and their patients,” Hamid said. “During some of the first times that I interacted with these patients in medical school, I found that they were so kind and wanted to impart knowledge, not about their illness, but about their lives. I enjoyed that and felt that being an oncologist would allow me to serve a broader population.” 

Oncology also had another advantage. The pathophysiology of cancer fascinated Hamid, and the quickening pace of discovery suggested that breakthrough treatments might soon be possible. He stayed on briefly at LAC + USC Medical Center as associate director of the Melanoma Center at USC Norris Comprehensive Cancer Center, where he worked closely with Jeffrey S. Weber, MD, PhD. 

“I had the good fortune of ending up at USC Norris. It was well stocked with experts in all kinds of treatment—surgical oncology, radiation oncology, medical oncology—but for whatever reason, there was a huge amount of immunotherapy going on: biochemotherapy, high-dose IL-2, and the beginning of the checkpoint strategy,” Hamid said. 

“Through fate, I ended up working with Jeff Weber as an intern, a resident, and a fellow, and I decided to stay on and do basic clinical research and drug design on immunotherapies and checkpoint inhibitors,” Hamid said. “Like many of the people who started the way I did with checkpoint inhibitors and immunotherapy, the successes in the lab made you want to move them rapidly into human trials, and so that is where I went.” 

Weber, who is now deputy director of the Perlmutter Cancer Center at NYU Langone Health in New York, New York, still collaborates frequently with Hamid: They coauthored 5 papers in 2021 and are cochairs of the melanoma conference. Weber said Hamid’s success stems from his former protégé’s personal qualities. 

“He’s one of the most dedicated, hard-working, insightful, and admirable individuals it has been my pleasure to work with over the years,” Weber said. “His dedication to excellence in his craft as a physician is only matched by his dedication to his family.”

Vol. 23/No. 24 | Oncology Live®

Discrete Data Are Key to Realizing Electronic Health Records’ Full Potential

HPV, PD-L1 Move to the Forefront of Biomarkers for Head and Neck Cancers

Treatment Complexities Continue to Mount in Gynecologic Cancers

Melanoma Expert Focuses on Finding the Next Best Therapy