Reference
“Bevacizumab Erlotinib Switch Maintenance in Chemo-Responsive Advanced Gallbladder and Cholangiocarcinoma (BEER BTC): A Multicenter, Open-Label, Randomized, Phase II Trial” by Dr. Vikas Ostwal, et al., Journal of Clinical Oncology.
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Avastin Regimen Versus Monitoring May Be Beneficial in Cholangiocarcinoma
Key Takeaways
- Avastin-Tarceva combination improved progression-free survival in advanced gallbladder cancer and cholangiocarcinoma compared to active surveillance.
- The study reported a median PFS of 5.3 months for the combination group versus 3.1 months for active surveillance.
Patients with gallbladder cancer and cholangiocarcinoma may benefit from receiving Avastin plus Tarceva versus active surveillance.
A study found that patients with advanced gallbladder cancer who received Avastin and Tarceva as a switch maintenance therapy after first-line chemotherapy experienced improved progression-free survival compared to those who received active surveillance.
A treatment combination of Avastin (bevacizumab) and Tarceva (erlotinib) as switch maintenance (targeted therapy after first-line chemotherapy) improved outcomes for patients with advanced gallbladder and cholangiocarcinoma.
In a phase 2 study published in the Journal of Clinical Oncology, researchers found that the treatment combination improved progression-free survival (PFS; time patients live without their disease worsening or spreading) when the combination was used as switch maintenance.
Patients in the study were randomly assigned to two groups: active surveillance (close monitoring; 49 patients) or the Avastin-Tarceva combination (49 patients). Among the patient population, 80% had gallbladder cancer, according to the study. All patients in the study were from two centers located in India.
Among all patients, 83 experienced disease progression (worsening or spreading), which specifically included 39 patients in the Avastin-Tarceva group and 44 in the active surveillance group. Patients who experienced disease progression further received systemic therapy, with 30 of 49 patients in the combination group and 36 of 49 patients in the active surveillance group, researchers established.
Progression-Free Survival With Avastin-Tarceva Versus Active Surveillance
From patients in the intention-to-treat population, PFS was found to be longer in patients treated with Avastin-Tarceva versus active surveillance, according to the researchers.
At six months, the PFS was 44.3% and 21.9% in patients from the combination and active surveillance groups, respectively, the researchers noted. The median PFS for patients from the combination group was 5.3 months compared with 3.1 months for patients in the active surveillance group.
“[The Avastin and Tarceva] combination helps the patient to be off chemotherapy longer as compared to just active surveillance after six months of standard chemotherapy,” explained study author Dr. Vikas Ostwal during an email interview with CURE®.
Ostwal is a medical oncologist and associate professor of medical oncology at Tata Memorial Centre in Mumbai, India.
He explained that patients with advanced gallbladder cancer and cholangiocarcinoma typically receive a chemotherapy regimen of gemcitabine and cisplatin for six months. After, patients may receive immunotherapy plus the chemotherapy regimen, immunotherapy alone or with the chemotherapy regimen as maintenance therapy following the initial six months of the same regimen, he said.
Of note, Ostwal explained that the “continuation of chemotherapy and immunotherapy can lead to significant physical and financial toxicities,” meaning potential challenges with side effects and financial burdens.
Because of these possible factors, he also noted that active surveillance is common among patients with advanced gallbladder cancer and cholangiocarcinoma.
“Active surveillance is common after six months of standard gemcitabine-cisplatin-based chemotherapy,” he said. “Continuation of chemotherapy and immunotherapy can lead to significant physical and financial toxicities.”
Side Effects Related to Avastin-Tarceva in Gallbladder Cancer and Cholangiocarcinoma
In patients who were treated with Tarceva, some patients experienced grade 3 (severe) side effects, researchers reported. These side effects included acneiform rash (small acne-like bumps) in one patient, oral mucositis (swelling and sores in the mouth) in one patient and bleeding in one patient after receiving Avastin.
Among patients who were treated with Tarceva, six patients temporarily stopped treatment with Tarceva because of treatment-related side effects. To note, two of six patients who temporarily stopped treatment experienced grade 2 (mild) proteinuria (high levels of protein in urine) and esophageal varices hemorrhages (bleeding of abnormal veins in the lower part of the throat). Importantly, there were no treatment-related deaths reported from the study.
“The study adds an additional option for these patients to have the chemotherapy-free interval after six months of standard therapy, which can also reduce the financial burden apart from the side effects of the chemotherapy,” Ostwal said.
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