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ASCO 2016 Highlights

TON - September 2016, Vol 9, No 5 - Conference Correspondent
Alice Goodman

Improving the Delivery of and Access to High-Quality Cancer Care

More than 30,000 healthcare professionals and others from around the world attended the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. The theme of this year’s meeting was Collective Wisdom: The Future of Patient-Centered Care and Research. More than 5200 abstracts were submitted, each intended to advance the delivery and accessibility of high-quality cancer care.

The following are selected presentations presented at the 2016 American Society of Clinical Oncology Annual Meeting, June 3-7, 2016. We hope you find them of interest.

In This Article

Novel Antibody Shows Promising Results in Gastric Cancer

The first-in-class antibody IMAB362 extended survival in patients with advanced gastric cancer when added to standard chemotherapy with epirubicin, oxaliplatin, and capecitabine (EOX), according to results of the international, multicenter, randomized phase 2 FAST study.

Median overall survival (OS) was significantly longer in patients treated with IMAB362 than in those treated with standard chemotherapy, and was more robust in patients with the highest levels of claudin18.2 (CLDN18.2) expression than in those without.

IMAB362 is a chimeric monoclonal antibody that mediates specific killing of CLDN18.2-positive cancer cells via immune effector mechanisms. CLDN18.2 is a tight junction protein commonly expressed in approximately 70% to 90% of biliary duct, pancreatic, gastric, and mucinous ovarian cancers.

The study included 161 patients with advanced or recurrent gastric, esophageal, or gastroesophageal junction adenocarcinoma with CLDN18.2 expression of at least 2+ intensity in >40% of cancer cells, and an Eastern Cooperative Oncology Group performance status of 0 or 1. None of the patients was eligible for trastuzumab.

All 161 patients received first-line treatment with standard chemotherapy using the triplet EOX combination (epirubicin and oxaliplatin on day 1 of each cycle, and capecitabine twice daily on days 1-21 of each cycle) for a maximum of 8 cycles. In addition, 77 patients were treated with a loading dose of IMAB362 800 mg/m2, followed by IMAB362 600 mg/m2; the remaining 84 patients served as the control group.

An additional group of 85 patients were treated with the same first-line chemotherapy regimen plus a higher dose of IMAB362, but these results were not reported at the meeting.

Patients receiving the antibody plus chemotherapy had significantly improved progression-free survival (PFS) compared with chemotherapy alone—7.9 months versus 4.8 months, respectively (P = .0001). OS was also significantly superior in patients treated with the antibody plus chemotherapy—13.2 months versus 8.4 months, respectively (P = .0001).

Patients with the highest level of CLDN18.2 expression (at least 2+ intensity in >70% of tumor cells) achieved more robust benefit with the addition of the antibody to chemotherapy. In this subgroup, median PFS was 7.2 months versus 5.6 months in controls (P  ≤.0005). Median OS was 16.7 months versus 9 months, respectively (P  ≤.0005).

Adverse events were manageable. The most common antibody-related adverse events were vomiting, neutropenia, and anemia. The rates of grade 3 and 4 neutropenia were higher in the antibody group (32.5%) compared with controls (21.4%). Rates of grade 3 and 4 vomiting were 10.4% versus 3.6%, respectively.

Commenting on this trial, Peter Enzinger, MD, Senior Physician, Dana-Farber Cancer Institute, Boston, MA, said that these results were promising, but before moving on to phase 3 clinical trials of the antibody, it would be good to confirm that the expression of CLDN18.2 is a biomarker, and to determine which drugs are best partnered with this new antibody, based on toxicity profiles.

Source: Al-Batran S-E, Schuler MH, Zvirbule Z, et al. FAST: an international, multicenter, randomized, phase II trial of epirubicin, oxaliplatin, and capecitabine (EOX) with or without IMAB362, a first-in-class anti-CLDN18.2 antibody, as first-line therapy in patients with advanced CLDN18.2+ gastric and gastroesophageal junction (GEJ) adenocarcinoma. Abstract LBA4001.

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Nivolumab Improves Outcomes in Patients with Anal Cancer

Immunotherapy has gained a foothold in the treatment of melanoma and lung cancer, and is also being studied in other solid tumors. Results from a small, prospective phase 2 trial suggest that the anti–PD-1 monoclonal antibody nivolumab can improve outcomes in patients with metastatic anal cancer.

In a study of 37 patients with refractory metastatic squamous-cell carcinoma of the anal canal, nivolumab achieved a 24% response rate, including 2 complete responses.

“Anal cancer refractory to chemotherapy and radiation can respond to PD-1 inhibitory agents. [This is] good news to bring home to our clinics,” said Richard Goldberg, MD, The Ohio State University Comprehensive Cancer Center–James Cancer Hospital and Solove Research Institute, Columbus. He included this presentation in a “Highlights of the Day” session, but was not involved in this study.

This was the first prospective phase 2 study completed in patients with refractory squamous-cell carcinoma of the anal canal in the United States. Single-agent nivolumab was well-tolerated and met the primary end point of response.

“This opens the door to the use of immunotherapy in another one of the virally associated cancers, this one with human papilloma virus,” Dr Goldberg said.

“There is currently no standard of care for patients with metastatic refractory disease, which comprises about 20% of all patients with squamous cell carcinoma of the anal canal,” said lead author Cathy Eng, MD, Professor, Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston.

The study, which is part of the National Cancer Institute’s Experimental Therapeutics Clinical Trials Network, enrolled 37 patients treated with single-agent nivolumab. Median number of therapies was 2, and PD ligand 1 (PD-L1) expression was not required for participation in the study.

Of 34 patients evaluable for response, there were 2 (5.4%) who achieved complete responses, and 7 (18.9%) with partial responses, for an overall response rate of 24.3%. Seventeen (45.9%) patients had stable disease, and 8 (21.6%) had progressive disease. Median PFS was 3.9 months.

Baseline levels of PD-L1 expression, PD-1 expression, and CD8 were increased in responders compared with nonresponders. There were few grade 3 toxicities, which included fatigue, anemia, rash, and hyperthyroidism, and 1 case of pneumonitis.

Source: Morris VK, Ciombor KK, Salem ME, et al. NCI9673: a multi-institutional eETCTN phase II study of nivolumab in refractory metastatic squamous cell carcinoma of the anal canal (SCCA). Abstract 3503.

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Brentuximab as an Alternative to Radiation Therapy

Brentuximab vedotin appears to be a promising alternative to radiation for consolidation therapy in patients with limited-stage Hodgkin lymphoma after induction chemotherapy with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).

The current standard of care for these patients is either 2 to 4 cycles of ABVD followed by consolidation radiation, or 3 to 6 cycles of ABVD without radiation. Radiation appears to improve PFS but not OS, so its use in patients with limited-stage Hodgkin lymphoma remains controversial, explained Steven I. Park, MD, Director, Lymphoma Program, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill.

The phase 2 study presented by Dr Park showed that >90% of patients with limited-stage, nonbulky Hodgkin lymphoma treated with ABVD and consolidation brentuximab vedotin were positron-emission tomography (PET)-negative. Moreover, patients who were PET-negative after brentuximab vedotin consolidation remained in remission, with an estimated 1-year PFS of 100%.

“Radiation therapy, although effective, leads to long-term complications, including increased risk of secondary malignancies,” he said. “Patient(s) who receive radiation to the mediastinum are at increased risk for breast cancer, lung cancer, and thyroid malignancies, and there is an increased risk of cardiac complications.”

When treating a patient with limited-stage Hodgkin lymphoma, secondary complications are an important consideration, because these patients have a fairly long life expectancy, he explained. In the study, the patients’ median age was 29 years.

The phase 2 multicenter study enrolled 41 patients with newly diagnosed, limited-stage, non-bulky Hodg­kin lymphoma. They received 2 cycles of ABVD followed by an interim PET scan. Those with favorable disease characteristics who were PET-negative went on to consolidation therapy with brentuximab vedotin every 3 weeks for 6 cycles. The remaining patients were treated with an additional 2 to 4 cycles of ABVD based on risk factors and interim PET scans, and then with brentuximab vedotin consolidation. Those who were PET-negative after consolidation did not receive additional therapy, whereas PET-positive patients were treated with radiation.

After 2 cycles of ABVD, 72.5% of patients were PET-negative; after completion of brentuximab vedotin consolidation therapy, 94.4% were PET-negative.

At a median follow-up of 17 months, estimated 1-year PFS was 91%, and estimated 1-year OS was 97%. Patients who were PET-negative after 2 cycles of ABVD had an estimated 1-year PFS of 96% compared with 79% in those who were PET-positive at interim scan.

After consolidation therapy, 2 patients relapsed. The most common adverse event was peripheral neuropathy. Other common adverse events included rash, fatigue, nausea, and neutropenia

Source: Park SI, Olajide OA, Reddy NM, et al. A phase 2 trial of ABVD followed by brentuximab vedotin consolidation in limited stage non-bulky Hodgkin lymphoma. Abstract 7508.

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Adjuvant Temozolomide for Rare Brain Cancer

Adjuvant temozolomide given after radiation improved survival in patients with anaplastic glioma without 1p/19q co-deletion, a rare disease, according to early results from the phase 3 CATNON intergroup clinical trial.

Estimated 5-year survival rates were 56% when patients received radiotherapy plus temozolomide, versus 44% without adjuvant temozolomide. Use of temozolomide delayed disease progression by >2 years in this trial of a very rare form of brain cancer.

Previous studies suggested that tem­ozolomide during and after radiation improved outcomes in glioblastoma, but chemotherapy after radiotherapy had no impact on anaplastic glioma, and outcomes were worse in patients with no 1p/19q co-deletion.

The CATNON clinical trial was designed to determine the role of temozolomide in this worse-prognosis group of patients.

“Until this study, doctors had no evidence to support the use of adjuvant temozolomide in patients with grade 3 anaplastic glioma. These findings should expand treatment choices and change the way we treat patients with this rare form of brain cancer,” said Martin J. Van Den Bent, MD, Neuro-Oncologist, Erasmus MC Cancer Center, Rotterdam, the Netherlands.

Patients with no 1p/19q co-deletion tend to respond better to chemotherapy and live longer, he explained. The CATNON trial randomized 745 patients to 1 of 4 groups: radiation alone, radiation with concurrent temozolomide, radiation with adjuvant temozolomide, and radiation with concurrent and adjuvant temozolomide.

Median time to disease progression was more than double in patients treated with adjuvant temozolomide compared with those who were not: 42.8 months versus 19 months, respectively.

Median OS has not yet been reached in those who received adjuvant temozolomide. Results of temozolomide given only during radiation are not yet available, and expected in the year 2020.

The most common toxicities in the temozolomide study arms were hematologic, with grades 3 and 4 toxicity reported in 8% to 13% of patients.

The next step is to identify biomarkers for response to temozolomide. Candidate biomarkers include MGMT promoter methylation, and isocitrate dehydrogenase mutational status.

Source: Van Den Bent MJ, Erridge S, Vogelbaum MA, et al. Results of the interim analysis of the EORTC randomized phase III CATNON trial on concurrent and adjuvant temozolomide in anaplastic glioma without 1p/19q co-deletion: an intergroup trial. Abstract LBA2000.

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Internet-Mediated Application Improves Survival in Patients with Lung Cancer

Patients with stage III and IV lung cancer who used an Internet-mediated application called Moovcare to track their symptoms had prolonged survival compared with those assigned to standard follow-up care in a randomized phase 3 clinical trial.

At 1 year, 75% of the patients randomized to use the application were alive versus 49% of those in the standard care follow-up arm.

In addition, use of the application reduced resource utilization, including computed tomography (CT) scans, visits to the physician, and patient phone calls to the physician’s office.

“If a drug could save this many lives it would make national headlines,” said Fabrice Denis, MD, PhD, a researcher at the Institut Inter-regional de Cancérologie Jean Bernard, Le Mans, France.

“Through personalized follow-up using this convenient and simple online application, we can detect complications and signs of relapse and offer appropriate care earlier. This approach introduces a new era of follow-up in which patients can give and receive continuous feedback between visits to their oncologist,” he told listeners.

Moovcare is a prototype in development, and not yet commercially available. The way the application works allows patients to self-report the status of 12 clinical symptoms of disease progression weekly. Caregivers were also allowed to enter information on behalf of the patient about emerging symptoms. The application analyzed the feedback on the 12 symptoms, and reported results to the oncologist. An algorithm assessed changes in symptoms, which triggered e-mail alerts for the physician, who would confirm the need for visits and changes in therapy.

The multicenter, randomized study included 121 patients with stage III/IV lung cancer who completed initial chemotherapy, radiation therapy, or surgery. Patients were randomized to Internet-mediated follow-up with the application (n = 60), or standard care follow-up (n = 61), with physician visits and CT scans every 3 to 6 months (or more often if the investigator chose). Patients randomized to the application had the same number of physician visits, but 3 times fewer scans.

Relapse rates were similar in both groups: 51% for standard care follow-up, and 49% for the application. Because the symptoms were reported earlier in the application group, these patients had better performance status, and 74% were able to tolerate full recommended treatment at relapse versus one-third of patients randomized to standard follow-up, which explains the improved survival rates.

Overall quality of life (QOL), as assessed by the Functional Assessment of Cancer Therapy (FACT) Lung (L), FACT-General, and FACT-L Trial Outcome Index, was better in the group that used the application. Use of the application also reduced the number of imaging tests per patient per year by 50%.

Other studies have looked at telemedicine use in patients with cancer, but, according to the researchers, this is the first to show improved survival with an application versus standard care follow-up. It is also the first study to use an algorithm for early detection of symptomatic relapse or complication, triggering early treatment or supportive care.

The application also reduced the frequency of patient and caregiver phone calls to the physician. The application did not increase the time burden on the oncologist: it took the oncologist approximately 15 minutes per week to follow 60 patients using the application.

Use of the application is now being studied in patients with lymphoma, where CT scans are also used to follow patients, Dr Denis said.

Source: Denis F, Lethrosne C, Pourel N, et al. Overall survival in patients with lung cancer using a Web-application-guided follow-up compared to standard modalities: results of phase III randomized trial. Abstract LBA9006.

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Burnout Among Oncology Physician Assistants

Burnout is common among physician assistants (PAs) in oncology, yet it coexists with high career/specialty satisfaction, according to a national survey presented by Eric D. Tetzlaff, MHS, PA-C, Advanced Practice Clinician, Fox Chase Cancer Center, Philadelphia, PA.

“The overall rate of burnout for PAs in oncology was 35% in our study. Fortunately, career satisfaction is 90%, so those with burnout won’t leave the profession,” Mr Tetzlaff said in an interview.

PAs are not the only oncology-related profession to experience burnout, he continued. A separate study of oncologists found a 45% burnout rate.

Mr Tetzlaff believes that the relationship between the PA and collaborating physician is key to reducing the rate of burnout. “The more the PA and collaborating physician disagreed, the higher the rate of burnout among PAs. This makes the PA feel not valued,” he said.

Of 855 PAs sent the survey, response rate was 29.2% (n = 250). Respondents were grouped by age: 26.4% were 18 to 34 years, 37.6% were 35 to 44 years, 21.2% were 45 to 54 years, and 14.8% were 55 to 64 years. Approximately 90% were female, 55% practiced in an academic setting, 40% were in private practice, and 5% were in “other” practice settings. Approximately two-thirds practiced in urban areas, 75% were medical oncology PAs, and 74% practiced in an outpatient setting.

Of those surveyed, 34.8% reported burnout. High scores on indices of emotional exhaustion (17.2%), depersonalization (4.4%), or both (13.2%) contributed to overall rate of burnout.

Despite this, 86.7% said they would choose to be a PA again, and 88.8% said they would choose to be an oncology PA again.

Significant factors associated with burnout included an increase in hours worked per week (P = .0017), and feeling unfairly compensated for the work they were doing (P <.0001). Age, sex, practice setting, PA practice elements, and geographic region were not significantly associated with burnout.

Medical and surgical oncology PAs had higher rates of burnout than radiation oncology PAs: 38.8%, 30%, and 15.4%, respectively.

An increase in the rate of burnout was observed in PAs who did not feel valued by their collaborating oncologist, who were not encouraged to achieve professional goals, or whose contributions to the practice were not acknowledged by the collaborating oncologist.

Eighty-four percent said they were likely to remain in the field in 2 years, 10% were not sure, and 6% said they were unlikely to remain.

“Attention needs to be paid to the collaborative relationship between the oncologist and PA. This has an impact on patients but also impacts provid­ers and could reduce burnout,” Mr Tetzlaff said.

Source: Tetzlaff ED, Hylton HM, Ruth K, Wong Y-N. Provider characteristics and their association with burnout and career satisfaction among physician assistants in oncology. Abstract 6521.

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Clinicians’ Perception of Risk and Quality of Life Affect Patient Outcomes

Women with early breast cancer and a favorable prognosis often overestimate their risk for recurrence, which compromises their QOL, according to a presentation of preliminary data that are part of a larger study.

The actual risk of recurrence among women with early breast cancer is <5% for ductal carcinoma in situ (DCIS) and <10% for invasive breast cancer. The large study found that 38% of patients with DCIS and 27% of patients with low-risk invasive breast cancer substantially overestimated their risk for recurrence.

“We looked at the degree to which women with favorable prognosis overestimate their risk of recurrence and found it was substantial. This is important because these women are worried and this could lead to increased utilization of services such as imaging, more tests, and more doctor visits. Patients with a favorable prognosis, such as DCIS or low-risk invasive breast cancer, should be able to go on with their lives,” said lead author Sarah T. Hawley, PhD, Professor, Division of General Medicine, University of Michigan Health System, Ann Arbor.

“Clinicians should be aware of the association between overestimation of risk, quality of life, and worry, and make more effort to communicate with these women and reassure them that they are at low risk. It is impor­tant to give patients a sense of their actual posttreatment risk of recurrence,” she stated.

The survey included 3880 women with newly diagnosed, early-stage breast cancer from the SEER registries of Georgia and Los Angeles County who had surgical treatment in 2013 and 2014. Surveys were sent approximately 2 months posttreatment, with a response rate of 71%. The final sample on which the study was based totaled 1025 women with DCIS or low-risk invasive breast cancer (stage I, ER+/HER2−, grades 1-2).

Mean age overall was 61 years. Numeric overestimation was significantly associated with nonwhite race, more education, family history, invasive stage, and symptom bother (P <.05 for all). Descriptive overestimation was significantly associated with family history and symptom bother (P <.05 for both).

When respondents were asked about the frequency of worry about recurrence, those with low-risk invasive breast cancer were approximately 50% more likely to worry than those with DCIS. Both numeric and descriptive overestimation measures of risk were associated with worse QOL on the Patient-Reported Outcomes Measurement Information System scale.

However, descriptive overestimation was more strongly associated with poor outcomes than was numeric overestimation, suggesting that clinicians should be discussing actual risk in ways that patients can clearly understand.

Source: Hawley ST, Janz NK, Griffith KA, et al. Recurrence risk perception and quality of life after treatment of breast cancer. Abstract 6516.

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Last modified: September 14, 2016