1. Feasibility Study of Adjuvant Chemotherapy with Carboplatin and Nab-Paclitaxel for Completely Resected NSCLC
- Author
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Kazuyuki Kobayashi, Masako Yumura, Naoko Katsurada, Masatsugu Yamamoto, Shuntaro Tokunaga, Hiroshi Kamiryo, Yoshihiro Nishimura, Kiyoko Koyama, Tatsunori Kiriu, Yoshimasa Maniwa, Daisuke Tamura, Yukihisa Hatakeyama, Ryota Dokuni, Yugo Tanaka, Daisuke Hazama, Motoko Tachihara, and Kyosuke Nakata
- Subjects
0301 basic medicine ,Cisplatin ,Oncology ,Chemotherapy ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Phases of clinical research ,Neutropenia ,medicine.disease ,Vinorelbine ,Carboplatin ,03 medical and health sciences ,chemistry.chemical_compound ,Regimen ,030104 developmental biology ,0302 clinical medicine ,Paclitaxel ,chemistry ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,business ,medicine.drug - Abstract
Purpose Adjuvant chemotherapy with cisplatin (CDDP) plus vinorelbine is the standard regimen for the treatment of non-small cell lung cancer (NSCLC). However, CDDP elicits severe toxic effects, including emesis, neurotoxicity, and renal damage; carboplatin (CBDCA) may be a feasible alternative for CDDP-unfit patients. CBDCA plus paclitaxel (PTX) adjuvant chemotherapy showed a survival benefit for patients with stage IB tumors >4 cm in size, while CBDCA plus nanoparticle albumin-bound (nab)-PTX showed greater efficacy and lower neurotoxicity than CBDCA plus PTX in advanced NSCLC. Here, we investigated the feasibility of using CBDCA plus nab-PTX as adjuvant chemotherapy for NSCLC. Patients and methods Patients with completely resected stage II or III NSCLC, with an Eastern Cooperative Oncology Group performance status of 0-1 and adequate kidney function, received four cycles of postoperative adjuvant chemotherapy with CBDCA (AUC=5 mg/mL/min, on day 1) and nab-PTX (100 mg/m2, on days 1, 8, and 15) administered every 4 weeks within 8 weeks after surgery. The study was designed as a prospective, single-center, Phase II study. The primary endpoint was the completion rate of chemotherapy; secondary endpoints were two-year relapse-free survival (RFS) and safety. The expected completion rate was 80%, with a 50% lower limit. Results Of 21 enrolled patients, 18 (85.7%) were CDDP-unfit owing to age (≥75 years old [n=11, 52.4%]) or mild renal impairment (n=7, 33.3%). Nineteen of the 21 enrolled patients were assigned to the intervention. The most common grade 3 or 4 adverse events were neutropenia (n=15, 78.9%) and anemia (n=3, 15.8%). The completion rate for the four cycles was 63.2% (95% CI, 38.4-83.7). Two-year RFS was 56.8% (95% CI, 29.7-76.9). Conclusion The completion rate for CBDCA plus nab-PTX as adjuvant chemotherapy for CDDP-unfit NSCLC patients did not reach treatment feasibility. Further dose modifications may be required in future studies.
- Published
- 2020
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