Phase II study of carboplatin, docetaxel and bevacizumab for chemotherapy-naïve patients with advanced non-squamous non-small cell lung cancer

• Published in: International journal of clinical oncology 2015-08, Vol.20 (4), p.659-667
• Main Authors: Takiguchi, Yuichi, Iwasawa, Shunichiro, Minato, Koichi, Miura, Yosuke, Gemma, Akihiko, Noro, Rintaro, Yoshimori, Kozo, Shingyoji, Masato, Hino, Mitsunori, Ando, Masahiro, Okamoto, Hiroaki
• Format: Article
• Language: English
• Subjects: Adenocarcinoma - drug therapy; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Bevacizumab - administration & dosage; Bevacizumab - adverse effects; Cancer Research; Carboplatin - administration & dosage; Carboplatin - adverse effects; Carcinoma, Non-Small-Cell Lung - drug therapy; Chemotherapy; Female; Humans; Lung cancer; Lung Neoplasms - drug therapy; Male; Medicine; Medicine & Public Health; Middle Aged; Oncology; Original Article; Surgical Oncology; Survival Analysis; Taxoids - administration & dosage; Taxoids - adverse effects
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-014-0755-6

Purpose To evaluate a 3-drug combination of carboplatin, docetaxel and bevacizumab as a front-line chemotherapy for patients with advanced non-squamous non-small cell carcinoma (NSCLC), a single arm phase II study was conducted. Methods Patients with stage IIIB/IV or postoperative recurrent non-squamous NSCLC were treated with carboplatin (targeted area under the curve of 6 mg h/L), docetaxel (60 mg/m 2 ), and bevacizumab (15 mg/kg) on day 1, repeated every 3 weeks for 4 to 6 cycles, followed by maintenance with bevacizumab every 3 weeks until disease progression or occurrence of predefined toxicity. The planned patient number was 40, and the primary endpoint was progression free survival (PFS) as assessed by independent reviewers. Results One patient refused the treatment after enrollment; thus, 39 patients were treated and analyzed. The 3-drug therapy was delivered for a median of 4 cycles, and 54 % of the patients proceeded to the maintenance therapy for a median of 4 cycles. The overall response rate was 74.4 % (29/39), with a 95 % confidence interval (CI) of 60.0 to 88.7 %. The median PFS and overall survival (OS) were 6.2 months (95 % CI, 4.8–8.5 months) and 22.4 months (95 % CI, 11.3–26.2 months), respectively. Toxicities of grade 3 or higher included neutropenia in 71.8 %, febrile neutropenia in 23.1 %, and hypertension in 38.5 % of the patients, but they were transient and manageable. Conclusion The primary endpoint was met. The regimen yielded promising results with an excellent overall response rate, PFS, and OS for chemotherapy-naïve patients with advanced non-squamous NSCLC. Further studies are warranted.