A phase II study of biweekly paclitaxel and carboplatin in elderly patients with advanced non-small cell lung cancer

Kenzo Soejima, Katsuhiko Naoki, Kota Ishioka, Morio Nakamura, Michie Nakatani, Ichiro Kawada, Hideo Watanabe, Ichiro Nakachi, Hiroyuki Yasuda, Ryosuke Satomi, Sohei Nakayama, Satoshi Yoda, Shinnosuke Ikemura, Hideki Terai, Takashi Sato, Keiko Ohgino, Daisuke Arai, Tetsuo Tani, Aoi Kuroda, Makoto Nishino & 1 others Tomoko Betsuyaku

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Abstract

Purpose: The number of elderly patients with advanced non-small cell lung cancer (NSCLC) is increasing. Although several studies have suggested the benefit of chemotherapy with a platinum doublet for elderly patients with advanced NSCLC, this treatment is still controversial in this age group. To evaluate the efficacy and tolerability of combination chemotherapy with biweekly paclitaxel and carboplatin for elderly patients with advanced NSCLC, we conducted a multicenter, non-randomized, open label, phase II trial. Methods: We recruited patients aged ≥70 years with clinical stage IIIB and IV NSCLC and ECOG performance status (PS) of 0-2. Patients received paclitaxel (90 mg/m2) and carboplatin (AUC = 2.5) on day 1 and 15, every 4 weeks. The primary endpoint was overall response rate (ORR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. Results: Sixty-five patients (median age 79 years; range 70-87 years) were enrolled. Forty-nine patients were men, and 48 were stage IV. The PS was 0, 1, and 2 in 28, 33, and 4 patients, respectively. The histological type of NSCLC was non-squamous in 69.3 % and squamous cell carcinoma in 30.7 % of patients. The median number of treatment cycles was 3 (range 1-6). The response rate was 29.4 % (95 % CI 18.7-43.0), and the disease control rate was 78.0 % (95 % CI 64.8-87.2). Median PFS and OS were 3.8 months (95 % CI 1.9-5.3) and 17.3 months (95 % CI 10.4-25.1), respectively. The most common grade 3 or 4 toxicities were neutropenia (27 %), leukopenia (15 %), infection (10 %), and anemia (8 %). Conclusion: The combination of biweekly paclitaxel and carboplatin was effective and well tolerated in elderly patients with advanced NSCLC.

Original languageEnglish
Pages (from-to)513-519
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume75
Issue number3
DOIs
Publication statusPublished - 2015

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Carboplatin
Paclitaxel
Non-Small Cell Lung Carcinoma
Chemotherapy
Cells
Disease control
Oncology
Platinum
Toxicity
Labels
Disease-Free Survival
Survival
Leukopenia
Combination Drug Therapy
Neutropenia
Area Under Curve
Anemia
Squamous Cell Carcinoma
Age Groups
Safety

Keywords

  • Carboplatin
  • Elderly
  • Non-small cell lung cancer
  • Paclitaxel
  • Phase II trial

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pharmacology
  • Pharmacology (medical)
  • Toxicology
  • Medicine(all)

Cite this

A phase II study of biweekly paclitaxel and carboplatin in elderly patients with advanced non-small cell lung cancer. / Soejima, Kenzo; Naoki, Katsuhiko; Ishioka, Kota; Nakamura, Morio; Nakatani, Michie; Kawada, Ichiro; Watanabe, Hideo; Nakachi, Ichiro; Yasuda, Hiroyuki; Satomi, Ryosuke; Nakayama, Sohei; Yoda, Satoshi; Ikemura, Shinnosuke; Terai, Hideki; Sato, Takashi; Ohgino, Keiko; Arai, Daisuke; Tani, Tetsuo; Kuroda, Aoi; Nishino, Makoto; Betsuyaku, Tomoko.

In: Cancer Chemotherapy and Pharmacology, Vol. 75, No. 3, 2015, p. 513-519.

Research output: Contribution to journalArticle

Soejima, K, Naoki, K, Ishioka, K, Nakamura, M, Nakatani, M, Kawada, I, Watanabe, H, Nakachi, I, Yasuda, H, Satomi, R, Nakayama, S, Yoda, S, Ikemura, S, Terai, H, Sato, T, Ohgino, K, Arai, D, Tani, T, Kuroda, A, Nishino, M & Betsuyaku, T 2015, 'A phase II study of biweekly paclitaxel and carboplatin in elderly patients with advanced non-small cell lung cancer', Cancer Chemotherapy and Pharmacology, vol. 75, no. 3, pp. 513-519. https://doi.org/10.1007/s00280-014-2673-8
Soejima, Kenzo ; Naoki, Katsuhiko ; Ishioka, Kota ; Nakamura, Morio ; Nakatani, Michie ; Kawada, Ichiro ; Watanabe, Hideo ; Nakachi, Ichiro ; Yasuda, Hiroyuki ; Satomi, Ryosuke ; Nakayama, Sohei ; Yoda, Satoshi ; Ikemura, Shinnosuke ; Terai, Hideki ; Sato, Takashi ; Ohgino, Keiko ; Arai, Daisuke ; Tani, Tetsuo ; Kuroda, Aoi ; Nishino, Makoto ; Betsuyaku, Tomoko. / A phase II study of biweekly paclitaxel and carboplatin in elderly patients with advanced non-small cell lung cancer. In: Cancer Chemotherapy and Pharmacology. 2015 ; Vol. 75, No. 3. pp. 513-519.
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T1 - A phase II study of biweekly paclitaxel and carboplatin in elderly patients with advanced non-small cell lung cancer

AU - Soejima, Kenzo

AU - Naoki, Katsuhiko

AU - Ishioka, Kota

AU - Nakamura, Morio

AU - Nakatani, Michie

AU - Kawada, Ichiro

AU - Watanabe, Hideo

AU - Nakachi, Ichiro

AU - Yasuda, Hiroyuki

AU - Satomi, Ryosuke

AU - Nakayama, Sohei

AU - Yoda, Satoshi

AU - Ikemura, Shinnosuke

AU - Terai, Hideki

AU - Sato, Takashi

AU - Ohgino, Keiko

AU - Arai, Daisuke

AU - Tani, Tetsuo

AU - Kuroda, Aoi

AU - Nishino, Makoto

AU - Betsuyaku, Tomoko

PY - 2015

Y1 - 2015

N2 - Purpose: The number of elderly patients with advanced non-small cell lung cancer (NSCLC) is increasing. Although several studies have suggested the benefit of chemotherapy with a platinum doublet for elderly patients with advanced NSCLC, this treatment is still controversial in this age group. To evaluate the efficacy and tolerability of combination chemotherapy with biweekly paclitaxel and carboplatin for elderly patients with advanced NSCLC, we conducted a multicenter, non-randomized, open label, phase II trial. Methods: We recruited patients aged ≥70 years with clinical stage IIIB and IV NSCLC and ECOG performance status (PS) of 0-2. Patients received paclitaxel (90 mg/m2) and carboplatin (AUC = 2.5) on day 1 and 15, every 4 weeks. The primary endpoint was overall response rate (ORR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. Results: Sixty-five patients (median age 79 years; range 70-87 years) were enrolled. Forty-nine patients were men, and 48 were stage IV. The PS was 0, 1, and 2 in 28, 33, and 4 patients, respectively. The histological type of NSCLC was non-squamous in 69.3 % and squamous cell carcinoma in 30.7 % of patients. The median number of treatment cycles was 3 (range 1-6). The response rate was 29.4 % (95 % CI 18.7-43.0), and the disease control rate was 78.0 % (95 % CI 64.8-87.2). Median PFS and OS were 3.8 months (95 % CI 1.9-5.3) and 17.3 months (95 % CI 10.4-25.1), respectively. The most common grade 3 or 4 toxicities were neutropenia (27 %), leukopenia (15 %), infection (10 %), and anemia (8 %). Conclusion: The combination of biweekly paclitaxel and carboplatin was effective and well tolerated in elderly patients with advanced NSCLC.

AB - Purpose: The number of elderly patients with advanced non-small cell lung cancer (NSCLC) is increasing. Although several studies have suggested the benefit of chemotherapy with a platinum doublet for elderly patients with advanced NSCLC, this treatment is still controversial in this age group. To evaluate the efficacy and tolerability of combination chemotherapy with biweekly paclitaxel and carboplatin for elderly patients with advanced NSCLC, we conducted a multicenter, non-randomized, open label, phase II trial. Methods: We recruited patients aged ≥70 years with clinical stage IIIB and IV NSCLC and ECOG performance status (PS) of 0-2. Patients received paclitaxel (90 mg/m2) and carboplatin (AUC = 2.5) on day 1 and 15, every 4 weeks. The primary endpoint was overall response rate (ORR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. Results: Sixty-five patients (median age 79 years; range 70-87 years) were enrolled. Forty-nine patients were men, and 48 were stage IV. The PS was 0, 1, and 2 in 28, 33, and 4 patients, respectively. The histological type of NSCLC was non-squamous in 69.3 % and squamous cell carcinoma in 30.7 % of patients. The median number of treatment cycles was 3 (range 1-6). The response rate was 29.4 % (95 % CI 18.7-43.0), and the disease control rate was 78.0 % (95 % CI 64.8-87.2). Median PFS and OS were 3.8 months (95 % CI 1.9-5.3) and 17.3 months (95 % CI 10.4-25.1), respectively. The most common grade 3 or 4 toxicities were neutropenia (27 %), leukopenia (15 %), infection (10 %), and anemia (8 %). Conclusion: The combination of biweekly paclitaxel and carboplatin was effective and well tolerated in elderly patients with advanced NSCLC.

KW - Carboplatin

KW - Elderly

KW - Non-small cell lung cancer

KW - Paclitaxel

KW - Phase II trial

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