Phase III trial of two versus four additional cycles in patients who are nonprogressive after two cycles of platinum-based chemotherapy in non-small-cell lung cancer

Oh Park Joon, Sang We Kim, Seok Ahn Jin, Cheolwon Suh, Shin Lee Jung, Soon Jang Joung, Kyung Cho Eun, Hyun Yang Sung, Jin Hyuk Choi, Seog Heo Dae, Young Park Suk, Sang Won Shin, Ju Ahn Myung, Seok Lee Jong, Ho Yun Young, Jae Won Lee, Keunchil Park

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Abstract

Purpose: This trial was conducted to determine the optimal duration of chemotherapy in Korean patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Patients with stages IIIB to IV NSCLC who had not progressed after two cycles of chemotherapy were randomly assigned to receive either four (arm A) or two (arm B) more cycles of third-generation, platinum-doublet treatment. Results: Of the 452 enrolled patients, 314 were randomly assigned to the groups. One-year survival rates were 59.0% in arm A and 62.4% in arm B, and the difference of 3.4% (95% CI, -8.0 to 4.8) met the predefined criteria for noninferiority. The median time to progression (TTP), however, was 6.2 months (95% CI, 5.7 to 6.7 months) in arm A and 4.6 months (95% CI, 4.4 to 4.8 months) in arm B, the difference of which is statistically significant (P = .001). The frequencies of hematologic and nonhematologic toxicities were similar in the two arms. Conclusion: This study confirms the noninferiority of overall survival with four cycles compared with six cycles of chemotherapy for the first-line treatment of advanced NSCLC and supports the current American Society of Clinical Oncology guidelines. Notably, patients receiving six cycles of chemotherapy compared with four cycles showed a favorable TTP, suggesting that further investigation of the new strategies of maintenance therapy with less toxic agents after three to four cycles of induction chemotherapy might be warranted to improve survival, with consideration of both ethnicity and pharmacogenomic signatures.

Original languageEnglish
Pages (from-to)5233-5239
Number of pages7
JournalJournal of Clinical Oncology
Volume25
Issue number33
DOIs
Publication statusPublished - 2007 Nov 20

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Platinum
Non-Small Cell Lung Carcinoma
Drug Therapy
Induction Chemotherapy
Survival
Poisons
Pharmacogenetics
Therapeutics
Survival Rate
Guidelines

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Phase III trial of two versus four additional cycles in patients who are nonprogressive after two cycles of platinum-based chemotherapy in non-small-cell lung cancer. / Joon, Oh Park; Kim, Sang We; Jin, Seok Ahn; Suh, Cheolwon; Jung, Shin Lee; Joung, Soon Jang; Eun, Kyung Cho; Sung, Hyun Yang; Choi, Jin Hyuk; Dae, Seog Heo; Suk, Young Park; Shin, Sang Won; Myung, Ju Ahn; Jong, Seok Lee; Young, Ho Yun; Lee, Jae Won; Park, Keunchil.

In: Journal of Clinical Oncology, Vol. 25, No. 33, 20.11.2007, p. 5233-5239.

Research output: Contribution to journalArticle

Joon, OP, Kim, SW, Jin, SA, Suh, C, Jung, SL, Joung, SJ, Eun, KC, Sung, HY, Choi, JH, Dae, SH, Suk, YP, Shin, SW, Myung, JA, Jong, SL, Young, HY, Lee, JW & Park, K 2007, 'Phase III trial of two versus four additional cycles in patients who are nonprogressive after two cycles of platinum-based chemotherapy in non-small-cell lung cancer', Journal of Clinical Oncology, vol. 25, no. 33, pp. 5233-5239. https://doi.org/10.1200/JCO.2007.10.8134
Joon, Oh Park ; Kim, Sang We ; Jin, Seok Ahn ; Suh, Cheolwon ; Jung, Shin Lee ; Joung, Soon Jang ; Eun, Kyung Cho ; Sung, Hyun Yang ; Choi, Jin Hyuk ; Dae, Seog Heo ; Suk, Young Park ; Shin, Sang Won ; Myung, Ju Ahn ; Jong, Seok Lee ; Young, Ho Yun ; Lee, Jae Won ; Park, Keunchil. / Phase III trial of two versus four additional cycles in patients who are nonprogressive after two cycles of platinum-based chemotherapy in non-small-cell lung cancer. In: Journal of Clinical Oncology. 2007 ; Vol. 25, No. 33. pp. 5233-5239.
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title = "Phase III trial of two versus four additional cycles in patients who are nonprogressive after two cycles of platinum-based chemotherapy in non-small-cell lung cancer",
abstract = "Purpose: This trial was conducted to determine the optimal duration of chemotherapy in Korean patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Patients with stages IIIB to IV NSCLC who had not progressed after two cycles of chemotherapy were randomly assigned to receive either four (arm A) or two (arm B) more cycles of third-generation, platinum-doublet treatment. Results: Of the 452 enrolled patients, 314 were randomly assigned to the groups. One-year survival rates were 59.0{\%} in arm A and 62.4{\%} in arm B, and the difference of 3.4{\%} (95{\%} CI, -8.0 to 4.8) met the predefined criteria for noninferiority. The median time to progression (TTP), however, was 6.2 months (95{\%} CI, 5.7 to 6.7 months) in arm A and 4.6 months (95{\%} CI, 4.4 to 4.8 months) in arm B, the difference of which is statistically significant (P = .001). The frequencies of hematologic and nonhematologic toxicities were similar in the two arms. Conclusion: This study confirms the noninferiority of overall survival with four cycles compared with six cycles of chemotherapy for the first-line treatment of advanced NSCLC and supports the current American Society of Clinical Oncology guidelines. Notably, patients receiving six cycles of chemotherapy compared with four cycles showed a favorable TTP, suggesting that further investigation of the new strategies of maintenance therapy with less toxic agents after three to four cycles of induction chemotherapy might be warranted to improve survival, with consideration of both ethnicity and pharmacogenomic signatures.",
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T1 - Phase III trial of two versus four additional cycles in patients who are nonprogressive after two cycles of platinum-based chemotherapy in non-small-cell lung cancer

AU - Joon, Oh Park

AU - Kim, Sang We

AU - Jin, Seok Ahn

AU - Suh, Cheolwon

AU - Jung, Shin Lee

AU - Joung, Soon Jang

AU - Eun, Kyung Cho

AU - Sung, Hyun Yang

AU - Choi, Jin Hyuk

AU - Dae, Seog Heo

AU - Suk, Young Park

AU - Shin, Sang Won

AU - Myung, Ju Ahn

AU - Jong, Seok Lee

AU - Young, Ho Yun

AU - Lee, Jae Won

AU - Park, Keunchil

PY - 2007/11/20

Y1 - 2007/11/20

N2 - Purpose: This trial was conducted to determine the optimal duration of chemotherapy in Korean patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Patients with stages IIIB to IV NSCLC who had not progressed after two cycles of chemotherapy were randomly assigned to receive either four (arm A) or two (arm B) more cycles of third-generation, platinum-doublet treatment. Results: Of the 452 enrolled patients, 314 were randomly assigned to the groups. One-year survival rates were 59.0% in arm A and 62.4% in arm B, and the difference of 3.4% (95% CI, -8.0 to 4.8) met the predefined criteria for noninferiority. The median time to progression (TTP), however, was 6.2 months (95% CI, 5.7 to 6.7 months) in arm A and 4.6 months (95% CI, 4.4 to 4.8 months) in arm B, the difference of which is statistically significant (P = .001). The frequencies of hematologic and nonhematologic toxicities were similar in the two arms. Conclusion: This study confirms the noninferiority of overall survival with four cycles compared with six cycles of chemotherapy for the first-line treatment of advanced NSCLC and supports the current American Society of Clinical Oncology guidelines. Notably, patients receiving six cycles of chemotherapy compared with four cycles showed a favorable TTP, suggesting that further investigation of the new strategies of maintenance therapy with less toxic agents after three to four cycles of induction chemotherapy might be warranted to improve survival, with consideration of both ethnicity and pharmacogenomic signatures.

AB - Purpose: This trial was conducted to determine the optimal duration of chemotherapy in Korean patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Patients with stages IIIB to IV NSCLC who had not progressed after two cycles of chemotherapy were randomly assigned to receive either four (arm A) or two (arm B) more cycles of third-generation, platinum-doublet treatment. Results: Of the 452 enrolled patients, 314 were randomly assigned to the groups. One-year survival rates were 59.0% in arm A and 62.4% in arm B, and the difference of 3.4% (95% CI, -8.0 to 4.8) met the predefined criteria for noninferiority. The median time to progression (TTP), however, was 6.2 months (95% CI, 5.7 to 6.7 months) in arm A and 4.6 months (95% CI, 4.4 to 4.8 months) in arm B, the difference of which is statistically significant (P = .001). The frequencies of hematologic and nonhematologic toxicities were similar in the two arms. Conclusion: This study confirms the noninferiority of overall survival with four cycles compared with six cycles of chemotherapy for the first-line treatment of advanced NSCLC and supports the current American Society of Clinical Oncology guidelines. Notably, patients receiving six cycles of chemotherapy compared with four cycles showed a favorable TTP, suggesting that further investigation of the new strategies of maintenance therapy with less toxic agents after three to four cycles of induction chemotherapy might be warranted to improve survival, with consideration of both ethnicity and pharmacogenomic signatures.

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