Dr. Marianne Sinn
The addition of erlotinib to gemcitabine adjuvant therapy provides no benefit in patients with R0-resected pancreatic cancer, according to results of the randomized, open-label, phase III CONKO-005 trial (Abstract 4007). Marianne Sinn, MD, of Charité–Universitätsmedizin Berlin, Germany, presented the study results during the Gastrointestinal (Noncolorectal) Cancer Oral Abstract Session on Sunday, May 31.
The prognosis for patients with pancreatic cancer remains poor. “Everybody will agree that further [treatment] improvements for [patients with] potentially resectable pancreatic cancer are urgently needed,” Dr. Sinn said.
Adjuvant gemcitabine has been shown to improve disease-free survival and overall survival in pancreatic cancer. Given that erlotinib has demonstrated efficacy in advanced pancreatic cancer, the CONKO-005 trial was undertaken to evaluate the potential benefit of adding erlotinib to adjuvant gemcitabine.
The trial enrolled 436 patients with R0-resected pancreatic cancer who were randomly assigned to gemcitabine (1 g/m2 on days 1, 8, and 15 every 29 days) with or without erlotinib (100 mg/day) for 24 weeks. Patients were assessed for recurrence every 3 months for 2 years and every 6 months thereafter.
The majority of resections involved the pancreatic head. Nearly 90% of patients had T3/T4 tumors, and approximately two-thirds of patients had lymph node involvement. The median interval from surgery to start of chemotherapy was between 6 and 7 weeks in both arms.
Investigators reported no significant difference in efficacy outcomes with gemcitabine and erlotinib versus gemcitabine alone as assessed by median disease-free survival (11.6 months in both arms) or median overall survival (24.6 vs. 26.5 months).
As expected, grade 3/4 rash occurred significantly more frequently in the erlotinib arm than in the control arm (7% vs. < 1%; p < 0.001). No association between development of rash and efficacy was noted. The incidence of grade 3/4 diarrhea was higher in the erlotinib arm (5% vs. 1%); other toxicities occurred at a similar rate between arms. Treatment duration was also similar between arms, with a median of 22 weeks.
Dr. Sinn did point out an apparent trend toward improved long-term survival among patients receiving erlotinib and gemcitabine. She hypothesized that it may be possible to identify patients who could benefit most from adjuvant erlotinib.
Discussant Kenneth Yu, MD, MSc, of Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, noted that the standard of care for patients with resected pancreatic cancer has seen little change in the past 10-15 years. “It’s important to remember that the CONKO-005 study was designed in an era when there were few active agents available,” Dr. Yu said.
Based on negative results from the LAP-07 trial of erlotinib plus gemcitabine in advanced pancreatic cancer, erlotinib has been dropped from the ongoing adjuvant RTOG 0848 study of gemcitabine with or without chemoradiation, Dr. Yu said. New strategies being evaluated include more active chemotherapy regimens and novel vaccine-based approaches. Dr. Yu added that the adjuvant setting may be ideal for new in vitro methods using tumor tissue to develop molecularly guided treatment approaches.
Watch the session: Visit the ASCO Virtual Meeting website.