Phase II trial of weekly nab-paclitaxel for previously treated advanced non–small cell lung cancer

Kumamoto thoracic oncology study group (KTOSG) trial 1301

Shinya Sakata, Sho Saeki, Isamu Okamoto, Kohei Otsubo, Kazutoshi Komiya, Ryotaro Morinaga, Yasuto Yoneshima, Yuichiro Koga, Aimi Enokizu, Hiroto Kishi, Susumu Hirosako, Emi Yamaguchi, Naoko Aragane, Shinji Fujii, Taishi Harada, Eiji Iwama, Hiroshi Semba, Yoichi Nakanishi, Hirotsugu Kohrogi

研究成果: ジャーナルへの寄稿記事

14 引用 (Scopus)

抄録

Objectives We performed an open-label, multicenter, single-arm phase II study (UMIN ID 000010532) to prospectively evaluate the efficacy and safety of nab-paclitaxel for previously treated patients with advanced non–small cell lung cancer (NSCLC). Methods Patients with advanced NSCLC who experienced failure of prior platinum-doublet chemotherapy received weekly nab-paclitaxel (100 mg/m2) on days 1, 8, and 15 of a 21-day cycle until disease progression or the development of unacceptable toxicity. The primary end point of the study was objective response rate (ORR). Results Forty-one patients were enrolled between September 2013 and April 2015. The ORR was 31.7% (90% confidence interval, 19.3%–44.1%), which met the primary objective of the study. Median progression-free survival was 4.9 months (95% confidence interval, 2.4–7.4 months) and median overall survival was 13.0 (95% confidence interval, 8.0–18.0 months) months. The median number of treatment cycles was four (range, 1–17) over the entire study period, and the median dose intensity was 89.1 mg/m2 per week. Hematologic toxicities of grade 3 or 4 included neutropenia (19.5%) and leukopenia (17.1%), with no cases of febrile neutropenia being observed. Individual nonhematologic toxicities of grade 3 or higher occurred with a frequency of <5%. Conclusion Weekly nab-paclitaxel was associated with acceptable toxicity and a favorable ORR in previously treated patients with advanced NSCLC. Our results justify the undertaking of a phase III trial comparing nab-paclitaxel with docetaxel in this patient population.

元の言語英語
ページ(範囲)41-45
ページ数5
ジャーナルLung Cancer
99
DOI
出版物ステータス出版済み - 9 1 2016

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Non-Small Cell Lung Carcinoma
Thorax
docetaxel
Confidence Intervals
Febrile Neutropenia
Leukopenia
Neutropenia
Platinum
Disease-Free Survival
Disease Progression
130-nm albumin-bound paclitaxel
Safety
Drug Therapy
Survival
Population
Therapeutics

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

これを引用

Phase II trial of weekly nab-paclitaxel for previously treated advanced non–small cell lung cancer : Kumamoto thoracic oncology study group (KTOSG) trial 1301. / Sakata, Shinya; Saeki, Sho; Okamoto, Isamu; Otsubo, Kohei; Komiya, Kazutoshi; Morinaga, Ryotaro; Yoneshima, Yasuto; Koga, Yuichiro; Enokizu, Aimi; Kishi, Hiroto; Hirosako, Susumu; Yamaguchi, Emi; Aragane, Naoko; Fujii, Shinji; Harada, Taishi; Iwama, Eiji; Semba, Hiroshi; Nakanishi, Yoichi; Kohrogi, Hirotsugu.

:: Lung Cancer, 巻 99, 01.09.2016, p. 41-45.

研究成果: ジャーナルへの寄稿記事

Sakata, S, Saeki, S, Okamoto, I, Otsubo, K, Komiya, K, Morinaga, R, Yoneshima, Y, Koga, Y, Enokizu, A, Kishi, H, Hirosako, S, Yamaguchi, E, Aragane, N, Fujii, S, Harada, T, Iwama, E, Semba, H, Nakanishi, Y & Kohrogi, H 2016, 'Phase II trial of weekly nab-paclitaxel for previously treated advanced non–small cell lung cancer: Kumamoto thoracic oncology study group (KTOSG) trial 1301', Lung Cancer, 巻. 99, pp. 41-45. https://doi.org/10.1016/j.lungcan.2016.06.009
Sakata, Shinya ; Saeki, Sho ; Okamoto, Isamu ; Otsubo, Kohei ; Komiya, Kazutoshi ; Morinaga, Ryotaro ; Yoneshima, Yasuto ; Koga, Yuichiro ; Enokizu, Aimi ; Kishi, Hiroto ; Hirosako, Susumu ; Yamaguchi, Emi ; Aragane, Naoko ; Fujii, Shinji ; Harada, Taishi ; Iwama, Eiji ; Semba, Hiroshi ; Nakanishi, Yoichi ; Kohrogi, Hirotsugu. / Phase II trial of weekly nab-paclitaxel for previously treated advanced non–small cell lung cancer : Kumamoto thoracic oncology study group (KTOSG) trial 1301. :: Lung Cancer. 2016 ; 巻 99. pp. 41-45.
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abstract = "Objectives We performed an open-label, multicenter, single-arm phase II study (UMIN ID 000010532) to prospectively evaluate the efficacy and safety of nab-paclitaxel for previously treated patients with advanced non–small cell lung cancer (NSCLC). Methods Patients with advanced NSCLC who experienced failure of prior platinum-doublet chemotherapy received weekly nab-paclitaxel (100 mg/m2) on days 1, 8, and 15 of a 21-day cycle until disease progression or the development of unacceptable toxicity. The primary end point of the study was objective response rate (ORR). Results Forty-one patients were enrolled between September 2013 and April 2015. The ORR was 31.7{\%} (90{\%} confidence interval, 19.3{\%}–44.1{\%}), which met the primary objective of the study. Median progression-free survival was 4.9 months (95{\%} confidence interval, 2.4–7.4 months) and median overall survival was 13.0 (95{\%} confidence interval, 8.0–18.0 months) months. The median number of treatment cycles was four (range, 1–17) over the entire study period, and the median dose intensity was 89.1 mg/m2 per week. Hematologic toxicities of grade 3 or 4 included neutropenia (19.5{\%}) and leukopenia (17.1{\%}), with no cases of febrile neutropenia being observed. Individual nonhematologic toxicities of grade 3 or higher occurred with a frequency of <5{\%}. Conclusion Weekly nab-paclitaxel was associated with acceptable toxicity and a favorable ORR in previously treated patients with advanced NSCLC. Our results justify the undertaking of a phase III trial comparing nab-paclitaxel with docetaxel in this patient population.",
author = "Shinya Sakata and Sho Saeki and Isamu Okamoto and Kohei Otsubo and Kazutoshi Komiya and Ryotaro Morinaga and Yasuto Yoneshima and Yuichiro Koga and Aimi Enokizu and Hiroto Kishi and Susumu Hirosako and Emi Yamaguchi and Naoko Aragane and Shinji Fujii and Taishi Harada and Eiji Iwama and Hiroshi Semba and Yoichi Nakanishi and Hirotsugu Kohrogi",
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TY - JOUR

T1 - Phase II trial of weekly nab-paclitaxel for previously treated advanced non–small cell lung cancer

T2 - Kumamoto thoracic oncology study group (KTOSG) trial 1301

AU - Sakata, Shinya

AU - Saeki, Sho

AU - Okamoto, Isamu

AU - Otsubo, Kohei

AU - Komiya, Kazutoshi

AU - Morinaga, Ryotaro

AU - Yoneshima, Yasuto

AU - Koga, Yuichiro

AU - Enokizu, Aimi

AU - Kishi, Hiroto

AU - Hirosako, Susumu

AU - Yamaguchi, Emi

AU - Aragane, Naoko

AU - Fujii, Shinji

AU - Harada, Taishi

AU - Iwama, Eiji

AU - Semba, Hiroshi

AU - Nakanishi, Yoichi

AU - Kohrogi, Hirotsugu

PY - 2016/9/1

Y1 - 2016/9/1

N2 - Objectives We performed an open-label, multicenter, single-arm phase II study (UMIN ID 000010532) to prospectively evaluate the efficacy and safety of nab-paclitaxel for previously treated patients with advanced non–small cell lung cancer (NSCLC). Methods Patients with advanced NSCLC who experienced failure of prior platinum-doublet chemotherapy received weekly nab-paclitaxel (100 mg/m2) on days 1, 8, and 15 of a 21-day cycle until disease progression or the development of unacceptable toxicity. The primary end point of the study was objective response rate (ORR). Results Forty-one patients were enrolled between September 2013 and April 2015. The ORR was 31.7% (90% confidence interval, 19.3%–44.1%), which met the primary objective of the study. Median progression-free survival was 4.9 months (95% confidence interval, 2.4–7.4 months) and median overall survival was 13.0 (95% confidence interval, 8.0–18.0 months) months. The median number of treatment cycles was four (range, 1–17) over the entire study period, and the median dose intensity was 89.1 mg/m2 per week. Hematologic toxicities of grade 3 or 4 included neutropenia (19.5%) and leukopenia (17.1%), with no cases of febrile neutropenia being observed. Individual nonhematologic toxicities of grade 3 or higher occurred with a frequency of <5%. Conclusion Weekly nab-paclitaxel was associated with acceptable toxicity and a favorable ORR in previously treated patients with advanced NSCLC. Our results justify the undertaking of a phase III trial comparing nab-paclitaxel with docetaxel in this patient population.

AB - Objectives We performed an open-label, multicenter, single-arm phase II study (UMIN ID 000010532) to prospectively evaluate the efficacy and safety of nab-paclitaxel for previously treated patients with advanced non–small cell lung cancer (NSCLC). Methods Patients with advanced NSCLC who experienced failure of prior platinum-doublet chemotherapy received weekly nab-paclitaxel (100 mg/m2) on days 1, 8, and 15 of a 21-day cycle until disease progression or the development of unacceptable toxicity. The primary end point of the study was objective response rate (ORR). Results Forty-one patients were enrolled between September 2013 and April 2015. The ORR was 31.7% (90% confidence interval, 19.3%–44.1%), which met the primary objective of the study. Median progression-free survival was 4.9 months (95% confidence interval, 2.4–7.4 months) and median overall survival was 13.0 (95% confidence interval, 8.0–18.0 months) months. The median number of treatment cycles was four (range, 1–17) over the entire study period, and the median dose intensity was 89.1 mg/m2 per week. Hematologic toxicities of grade 3 or 4 included neutropenia (19.5%) and leukopenia (17.1%), with no cases of febrile neutropenia being observed. Individual nonhematologic toxicities of grade 3 or higher occurred with a frequency of <5%. Conclusion Weekly nab-paclitaxel was associated with acceptable toxicity and a favorable ORR in previously treated patients with advanced NSCLC. Our results justify the undertaking of a phase III trial comparing nab-paclitaxel with docetaxel in this patient population.

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