The American Society of Clinical Oncology’s annual meeting is an excellent opportunity to learn about and assess the latest 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 top abstracts from ASCO 2019 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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Olaparib as maintenance treatment following first-line platinum-based chemotherapy (PBC) in patients (pts) with a germline BRCA mutation and metastatic pancreatic cancer (mPC): Phase III POLO trial
Comment: This global randomized trial demonstrates benefit for pancreas cancer patients with a germline mutation in BRCA1/2 with a poly (ADP-ribose) polymerase (PARP) inhibitor, olaparib. Cancer progression is reduced and duration of response is substantial, although survival data are immature. This represents the first targeted therapy in this illness.
Pembrolizumab with or without chemotherapy versus chemotherapy for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: The phase III KEYNOTE-062 study
Comment: This study demonstrates the value of immunotherapy over chemotherapy in first-line treatment of advanced gastric or gastro-esophageal cancers, particularly in patients selected with a biomarker.
Overall survival (OS) results of a phase III randomized trial of standard-of-care therapy with or without enzalutamide for metastatic hormone-sensitive prostate cancer (mHSPC): ENZAMET (ANZUP 1304), an ANZUP-led international cooperative group trial
Comment: This study establishes hormone therapy plus enzalutamide as a new standard of care for men with hormone-sensitive metastatic prostate cancer.
ANNOUNCE: A randomized, placebo (PBO)-controlled, double-blind, phase (Ph) III trial of doxorubicin (dox) + olaratumab versus dox + PBO in patients (pts) with advanced soft tissue sarcomas (STS)
Comment: This was a plenary presentation that described a failed phase III trial of doxorubicin and olaratumab in patients with soft tissue sarcoma. The phase II trial that led to the approval of olaratumab had a 12-month survival benefit that was not confirmed in this trial.
Effect of fixed-duration venetoclax plus obinutuzumab (VenG) on progression-free survival (PFS), and rates and duration of minimal residual disease negativity (MRD–) in previously untreated patients (pts) with chronic lymphocytic leukemia (CLL) and comorbidities
Comment: This study showed safety and efficacy of venetoclax in combination with obinutuzumab for older CLL patients with comorbidities and led to FDA approval of this regimen for frontline treatment. Prior to this, options for older/frail patients were limited to chlorambucil + obinutuzumab or ibrutinib. The new regimen has the advantage of being well-tolerated, with very high rates of complete remission and MRD negativity, and is time-limited to 12 months of treatment.
Neratinib + capecitabine versus lapatinib + capecitabine in patients with HER2+ metastatic breast cancer previously treated with ≥ 2 HER2-directed regimens: Findings from the multinational, randomized, phase III NALA trial
Comment: This study shows that all subsets of patients benefited from the combination of neratinib and capecitabine and the response rate was higher among this group compared to patients treated with a combination of lapatinib and capecitabine.
Phase III MONALEESA-7 trial of premenopausal patients with HR+/HER2− advanced breast cancer (ABC) treated with endocrine therapy ± : Overall survival (OS) results
Comment: This is an update from a previous presentation. At this point, the study is showing a survival advantage when ribociclib is combined with an endocrine treatment in premenopausal and perimenopausal patients. Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors such as ribociclib have been used in metastatic HR-positive breast cancer patients for several years. Those agents have doubled progression-free survival, but this is the first time that a CDK4/6 inhibitor or any targeted agent plus endocrine therapy has shown significantly longer overall survival versus endocrine therapy alone as initial therapy.
Impact of broadening clinical trial eligibility criteria for advanced non-small cell lung cancer patients: Real-world analysis
Comment: The use of expanded eligibility criteria would allow nearly twice as many people with non-small cell lung cancer to participate in clinical trials. The broadened eligibility criteria recommended by ASCO would allow enrollment of patients with another primary cancer if participation in the trial would not interfere with the patient’s safety or the efficacy of the therapy being tested.
Protocol-specified final analysis of the phase 3 KEYNOTE-048 trial of pembrolizumab (pembro) as first-line therapy for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC)
Comment: This abstract reports results from a phase III trial exploring pembrolizumab as a single agent, or in combination with systemic chemotherapy, in comparison to chemotherapy and cetuximab as first-line treatment for patients with recurrent or metastatic squamous cell head and neck cancer. It identified a survival benefit for the pembrolizumab arms, which was most pronounced in patients with high programmed death-ligand 1 (PD-L1) expression, and established a role for pembrolizumab in the initial management of these patients.
Gemcitabine and cisplatin (GP) induction chemotherapy (IC) plus concurrent chemoradiotherapy (CCRT) versus CCRT alone in locoregionally advanced nasopharyngeal carcinoma (NPC): A phase 3, multicenter, randomized controlled trial
Comment: This study identified a recurrence-free, overall and distant recurrence-free survival benefit from the use of induction gemcitabine and cisplatin followed by concurrent chemoradiation with cisplatin when compared to cisplatin chemoradiation alone in Asian patients with locoregionally advanced nasopharynx cancer. While not compared to the North American standard of chemoradiotherapy followed by adjuvant chemotherapy, this and other similar studies have established induction chemotherapy as another treatment standard in this disease.
Pathological response and survival with neoadjuvant therapy in melanoma: A pooled analysis from the International Neoadjuvant Melanoma Consortium (INMC)
Comment: Is neoadjuvant systemic therapy the wave of the future in oncologic treatment of cancer? Pathological complete response (pCR) was observed in 41% of patients from pooled studies of neoadjuvant melanoma; no melanoma patient with pCR from immunotherapy has experienced recurrence to date.