June 28, 2016

Top 10 ASCO Abstracts 2016

Favorites chosen by Cleveland Clinic’s Hematology and Medical Oncology staff

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The American Society of Clinical Oncology’s annual meeting is an excellent opportunity to learn about and assess new developments in cancer treatment. The staff of Cleveland Clinic Cancer Center’s Department of Hematology and Medical Oncology has compiled the following list of the 10 abstracts from ASCO 2016 that our physicians consider to be the most intriguing, the most clinically relevant, or that have the greatest potential to change the practice of clinical oncology in the near future.

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1. Abstract No. LBA4

Phase III Randomized Controlled Study of Daratumumab, Bortezomib and Dexamethasone versus Bortezomib and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma: CASTOR Study
Comment: This study ushers in the era of chemo-immunotherapy for the treatment of multiple myeloma, as was done for lymphoma by the introduction of rituximab two decades ago.

2. Abstract No. 104

PD-L1 Expression, Cancer Genome Atlas Subtype and Mutational Load as Independent Predictors of Response to Atezolizumab in Metastatic Urothelial Carcinoma (IMvigor210)
Comment: The immune checkpoint inhibitor atezolizumab (anti-PD-L1) showed significant activity and good tolerability in patients with locally advanced or metastatic urothelial cancer previously treated with platinum-based therapy in a phase II clinical trial that led to Food and Drug Administration approval on May 18, 2016, thus providing a new option for platinum-resistant advanced/metastatic urothelial cancer. The study evaluated potential predictive biomarkers and reported that PD-L1 expression on immune-infiltrating cells, TCGA molecular subtype and mutational load independently correlated with response to atezolizumab.

3. Late-Breaking Abstract No. LBA4500

Atezolizumab as 1L Therapy in Cisplatin-Ineligible Locally Advanced/Metastatic Urothelial Carcinoma: IMvigor210 Cohort 1

Comment: The immune checkpoint inhibitor atezolizumab (anti-PD-L1) showed significant activity in patients with locally advanced or metastatic urothelial cancer who could not receive cisplatin as first-line therapy. The response rate, tolerability and estimated median overall survival are promising and support further evaluation of this agent in cisplatin-ineligible patients with advanced/metastatic urothelial cancer. More clinical trials with atezolizumab are ongoing.

4. Abstract No. 8504

CONVERT: An International Randomized Trial of Concurrent Chemo-Radiotherapy Comparing Twice-Daily and Once-Daily Radiotherapy Schedules in Patients with Limited Stage Small Cell Lung Cancer and Good Performance Status

Comment: Concurrent chemotherapy and radiation is the standard of care for patients with limited stage small cell lung cancer (LS-SCLC), but the most effective schedule for delivering radiation has been controversial. A prior phase III trial suggested that twice-daily (BID) radiation conferred a survival benefit compared with once-daily (QD), but this finding has not been widely adopted. In this new randomized phase III trial of BID versus QD radiation with concurrent chemotherapy, there was no difference in survival between the two regimens, indicating that both are appropriate and demonstrating an impressive three-year survival rate for LS-SCLC patients in both arms of the trial (39 percent for QD and 43 percent for BID).

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5. Abstract No. 9008

Alectinib versus Crizotinib in ALK Inhibitor-Naive ALK-Positive Non-Small Cell Lung Cancer: Primary Results from the J-ALEX Study

Comment: The current standard of care for advanced ALK-gene fusion+ non-small cell lung cancer (NSCLC) has been daily crizotinib, with the second-generation ALK inhibitor alectinib recently approved for patients who develop resistance to crizotinib. In this randomized phase III trial in first-line treatment of ALK+ NSCLC, alectinib showed superiority over crizotinib, with a progression-free survival (PFS) hazard ratio of 0.34 (median PFS not reached [but in excess of 20 months] versus 10 months for crizotinib) and an objective response rate of 91.6 percent versus 78.9 percent, with significantly less toxicity. Alectinib should be considered a new standard of care for first-line ALK+ NSCLC.

6. Abstract No. 507

PALOMA-2: Primary Results from a Phase III Trial of Palbociclib Plus Letrozole Compared With Placebo plus Letrozole in Postmenopausal Women with ER+/HER2- Advanced Breast Cancer

Comment: CDK 4/6 inhibitors are clearly changing the treatment paradigm for metastatic breast cancer patients. Palbociclib, the first and only CDK 4/6 inhibitor approved by the Food and Drug Administration, has clearly expanded our nonchemotherapy options for ER-positive, metastatic breast cancer patients. This study confirms the phase II data and gives us more data to support using palbociclib in metastatic breast cancer.

7. Late-Breaking Abstract No. LBA1

A Randomized Trial (MA.17R) of Extending Adjuvant Letrozole for Five Years after Completing an Initial Five Years of Aromatase Inhibitor Therapy Alone or Preceded by Tamoxifen in Postmenopausal Women with Early-Stage Breast Cancer

Comment: This finding, though not completely novel, is practice-changing. Until now, there was no direct evidence for continuing endocrine therapy with aromatase inhibitors beyond five years in post-menopausal patients, although many of us have been doing that in clinical practice. Now we can make recommendations to continue aromatase inhibitors beyond five years, especially for high-risk patients, after discussing the risks and benefits.

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8. Abstract No. 5006

Cabazitaxel versus Docetaxel in Chemotherapy-Naive Patients with Metastatic Castration-Resistant Prostate Cancer: A Three-Arm Phase III Study (FIRSTANA)
Comment: This trial was a post-marketing commitment required by the Food and Drug Administration in 2010 during the approval of cabazitaxel for men with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel. FIRSTANA examined whether cabazitaxel 20mg/m2 or 25mg/m2 was superior to docetaxel 75mg/m2 in terms of overall survival in men with chemotherapy-naïve mCRPC (n= 1168). Although a greater objective response rate was observed in patients receiving cabazitaxel 25mg/m2, the median overall survival and progression-free survival were no different among the three treatment arms. These results solidify the role of docetaxel as the front-line chemotherapy of choice for men with mCRPC.

9. Late-Breaking Abstract No. LBA4006

ESPAC-4: A Multicenter, International, Open-Label Randomized Controlled Phase III Trial of Adjuvant Combination Chemotherapy of Gemcitabine and Capecitabine versus Monotherapy Gemcitabine in Patients with Resected Pancreatic Ductal Adenocarcinoma

Comment: The ESPAC-4 study, a randomized trial of single-agent gemcitabine versus combination gemcitabine with capecitabine, showed survival benefit for patients in the combination arm with minimal and manageable increase in toxicity. This study creates a new standard-of-care doublet therapy for patients with resected pancreas cancer and represents an important advance in the field.

10. Abstract No. 6009

Further Evaluations of Nivolumab versus Investigator’s Choice Chemotherapy for Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: CheckMate 141

Comment: This trial presents the first phase III evidence supporting benefit from the PD-1 inhibitors in the second-line management of recurrent/metastatic squamous cell head and neck cancer. It establishes a role for this approach as a treatment standard.

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