Open AccessPhase II Study of Modified Carboplatin Plus Weekly Nab‐Paclitaxel in Elderly Patients with Non‐Small Cell Lung Cancer: North Japan Lung Cancer Study Group Trial 1301
Author(s) -
Miyauchi Eisaku,
Inoue Akira,
Usui Kazuhiro,
Sugawara Shunichi,
Maemondo Makoto,
Saito Heisuke,
Fujita Yuka,
Kato Terufumi,
Suzuki Toshiro,
Harada Toshiyuki,
Watanabe Hiroshi,
Nakagawa Taku,
Ichinose Masakazu
Publication year - 2017
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2017-0059
Subject(s) - medicine , carboplatin , lung cancer , neutropenia , tolerability , regimen , gastroenterology , clinical endpoint , performance status , area under the curve , paclitaxel , oncology , toxicity , surgery , cancer , chemotherapy , randomized controlled trial , adverse effect , cisplatin
Lessons Learned Weekly nanoparticle albumin‐bound‐paclitaxel (75 mg/m 2 ) in combination with carboplatin (area under the curve 6 mg/mL/min) in elderly patients with previously untreated, advanced non‐small cell lung cancer showed favorable efficacy, was well tolerated, and showed less neuropathic toxicity. This modified regimen offers potential for the treatment of elderly patients.Background The CA031 trial suggested weekly nanoparticle albumin‐bound‐paclitaxel (nab‐PTX) was superior in efficacy to paclitaxel (PTX) once every 3 weeks when combined with carboplatin (CBDCA) for advanced non‐small cell lung cancer (NSCLC) patients; a subgroup analysis of elderly patients looked promising. In a multicenter phase II trial, we prospectively evaluated the efficacy and tolerability of modified CBDCA plus weekly nab‐PTX for elderly patients with untreated advanced NSCLC. Methods Eligible patients received CBDCA (area under the curve [AUC] 6 mg/mL/min) on day 1 and nab‐PTX (75 mg/m 2 ) on days 1, 8, and 15 every 4 weeks. The primary endpoint was an overall response rate (ORR), and secondary endpoints were progression‐free survival (PFS), overall survival (OS), and toxicity. Results Of 32 patients (median age of 78 years), 84% were male, 56% had stage IV NSCLC, and 56% had squamous cell carcinoma. ORR and disease control rates were 50% (95% confidence interval (CI): 33–67) and 94% (95% CI: 85–100), respectively. Median PFS and OS were 6.4 months (95% CI: 4.8–8.0) and 17.5 months (95% CI: 11.9–23.1), respectively. Grade ≥3 toxicities were neutropenia (47%), leukopenia (38%), anemia (34%), thrombocytopenia (25%), and anorexia (9%). Febrile neutropenia and treatment‐related deaths were not observed. Conclusion Modified CBDCA plus weekly nab‐PTX demonstrated significant efficacy and acceptable toxicities in elderly patients with advanced NSCLC.