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Phase 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
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...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
AlphaMed Press
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5469596/ https://www.ncbi.nlm.nih.gov/pubmed/28526722 http://dx.doi.org/10.1634/theoncologist.2017-0059 |
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author | 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 |
author_facet | 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 |
author_sort | Miyauchi, Eisaku |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5469596 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | AlphaMed Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-54695962017-07-13 Phase 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 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 Oncologist Clinical Trial Results 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. AlphaMed Press 2017-05-19 2017-06 /pmc/articles/PMC5469596/ /pubmed/28526722 http://dx.doi.org/10.1634/theoncologist.2017-0059 Text en © AlphaMed Press; the data published online to support this summary is the property of the authors. |
spellingShingle | Clinical Trial Results 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 Phase 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 |
title | Phase 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 |
title_full | Phase 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 |
title_fullStr | Phase 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 |
title_full_unstemmed | Phase 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 |
title_short | Phase 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 |
title_sort | phase 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 |
topic | Clinical Trial Results |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5469596/ https://www.ncbi.nlm.nih.gov/pubmed/28526722 http://dx.doi.org/10.1634/theoncologist.2017-0059 |
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