A randomized trial comparing induction chemotherapy followed by surgery with surgery alone for patients with stage IIIA N2 non-small cell lung cancer (JCOG 9209)

Kanji Nagai, Ryosuke Tsuchiya, Takashi Mori, Hiroto Tada, Yukito Ichinose, Teruaki Koike, Harubumi Kato, Keigo Takagi, Masahiro Kase, Takashi Kondo, Haruhiko Nakayama, Kohei Yokoi, Tsutomu Yasumitsu, Toru Sato, Yuichi Ozeki, Hideki Miyazawa, Osamu Kuwabara, Kenji Nakamura, Hideyuki Saeki

Research output: Contribution to journalArticlepeer-review

160 Citations (Scopus)

Abstract

Objective: We performed a prospective randomized trial in patients with potentially resectable stage IIIA N2 non-small cell lung cancer to confirm the efficacy of induction chemotherapy before surgical resection. Methods: Patients with stage IIIA N2 non-small cell lung cancer, all with histologically or cytologically confirmed metastases to the ipsilateral mediastinal lymph nodes, were randomly assigned to receive either three cycles of induction chemotherapy (cisplatin at 80 mg/m2 on 1 day and vindesine at 3 mg/m2 on 2 days) followed by surgery or surgery alone. Results: This trial was prematurely terminated because the accrual rate was too slow, which lowered the study's statistical power considerably. From June 1993 through April 1998, a total of 62 patients were enrolled, and 31 patients were assigned to each treatment group. The objective clinical response rate of induction chemotherapy was 28%. Complete resection was achieved in 20 patients in the induction chemotherapy group (65%) and 24 in the surgery alone group (77%). Median follow-up was 6.2 years. Median overall survivals were 17 months for the induction group and 16 months for the surgery alone group. The estimated 1-, 3-, and 5-year survivals, respectively, were 68% (95% confidence interval 51%-85%), 23% (95% confidence interval 8%-38%), and 10% (95% confidence interval 0%-20%) for the induction chemotherapy group and 65% (95% confidence interval 48%-82%), 26% (95% confidence interval 11%-41%), and 22% (95% confidence interval 7%-37%) for the surgery alone group. There was no statistically significant difference in survival between the groups (P = .5274). Treatment-related death was not observed in either group. Conclusion: This randomized trial to compare induction chemotherapy (cisplatin and vindesine) followed by surgery with surgery alone for patients with stage IIIA N2 non-small cell lung cancer did not demonstrate a survival difference between the groups, although this may have been because the statistical power was limited.

Original languageEnglish
Pages (from-to)254-260
Number of pages7
JournalJournal of Thoracic and Cardiovascular Surgery
Volume125
Issue number2
DOIs
Publication statusPublished - 2003 Feb 1

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Fingerprint Dive into the research topics of 'A randomized trial comparing induction chemotherapy followed by surgery with surgery alone for patients with stage IIIA N2 non-small cell lung cancer (JCOG 9209)'. Together they form a unique fingerprint.

Cite this