Chest
Volume 128, Issue 5, November 2005, Pages 3467-3474
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Clinical Investigations: SURGERY
Phase II Study of Neoadjuvant Chemotherapy With Gemcitabine and Vinorelbine in Resectable Non-small Cell Lung Cancer

https://doi.org/10.1378/chest.128.5.3467Get rights and content

Objective: We assessed the efficacy of a non-platinum-containing doublet chemotherapy of gemcitabine and vinorelbine as induction therapy prior to surgical resection in patients with stage IB-IIIA and selected stage IIIB non-small cell lung cancer (NSCLC). The primary clinical end point was radiographic disease response rate, and the secondary end points were pathologic response rate, treatment-related toxicity, surgical resectability and outcome, and overall and disease-free survival.

Methods: Patients underwent staging with CT of the chest and upper-abdomen, whole-body F-18 fluorodeoxyglucose positron emission tomography, bronchoscopy, and mediastinoscopy. The patients had to have medically and surgically resectable disease. Chemotherapy consisted of gemcitabine, 1,000 mg/m2, and vinorelbine, 25 mg/m2, administered on days 1, 8, 22, and 29. Imaging studies were repeated between days 43 and 50. Disease response was assessed by response evaluation criteria in solid tumors, and patients with resectable disease were offered surgery between days 50 and 70. Patients were followed up every 3 months for 2 years with chest CT.

Results: Between January 2000 and March 2004, 27 patients with stage IB NSCLC, 15 patients with stage II NSCLC, and 20 patients with stage III NSCLC were entered. After induction chemotherapy 34% (95% confidence interval [CI], 23 to 48%) had an objective radiographic response, 2% had a complete pathologic response, 90% underwent thoracotomy, and 77% underwent a complete resection. There were four deaths in the 6-week period following surgery, and there were no deaths related to chemotherapy. There were no unexpected morbidities from surgery or chemotherapy. The 1-year and 2-year overall survival rates were 80% (95% CI, 68 to 88%) and 65% (95% CI, 50 to 76%), and the median overall survival was 38.2 months.

Conclusions: Induction chemotherapy with gemcitabine and vinorelbine results in 1-year and 2-year survival rates and a median survival time comparable to those obtained with platinum-containing doublets. However, it appears to be less efficacious in terms of radiographic and pathologic response rates compared with platinum-containing chemotherapy doublets.

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MATERIALS AND METHODS

Patients with histologically confirmed NSCLC and stage IB (T2N0M0), IIA (T1N1M0), IIB (T2N1M0 and T3N0M0), or IIIA (T3N1M0 and T1-3N2M0) NSCLC were eligible for study participation. Patients with two lesions in one lobe (T4; stage IIIB) were also eligible, provided a lobectomy would encompass the satellite nodules. Patients with N2 disease were eligible if they were considered surgically resectable,ie, multistation lymph nodal involvement and bulky single-station lymph adenopathy were excluded

RESULTS

From January 2000 to March 2004, 62 patients were entered. The median age was 65 years (range, 32 to 82 years). Forty-five were men, and 17 were women. Pretreatment stages were IB (n = 27), IIA (n = 2), IIB (n = 13), IIIA (n = 15), and IIIB (n = 5). Adenocarcinoma was the most frequent histology (52%). Performance status was 0 in 33 patients and 1 in 29 patients. Seven patients reported weight loss, and 55 patients did not.

DISCUSSION

The study is the first to use a non-platinum doublet for induction chemotherapy in resectable NSCLC. The combination of vinorelbine and gemcitabine was well tolerated, and there was no chemotherapy-related mortality. Ninety percent of patients underwent thoracotomy, and 77% had a complete tumor resection. The 1-year and 2-year survival rates of 80% and 65% (87% and 74%, respectively, for patients with complete resections) and median survival time of 38.2 months were not different from those

ACKNOWLEDGMENTS

We wish to thank Amber Sapp and Carol Sherer for data management and clinical research support.

REFERENCES (34)

  • V Georgoulias et al.

    Platinum-based and non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a randomized multicentre trial.

    Lancet

    (2001)
  • Ruckdeschel JC, Schwartz AG, Bepler G, et al. Cancer of the lung: NSCLC and SCLC. In: Abeloff MD, Armitage JO,...
  • K Peck et al.

    Detection and quantitation of circulating cancer cells in the peripheral blood of lung cancer patients.

    Cancer Res

    (1998)
  • T Le Chevalier

    Results of the randomized International Adjuvant Lung Cancer Trial (IALT): cisplatin-based chemotherapy (CT) versus no CT in 1867 patients with resected non-small cell lung cancer [abstract].

    Proc Am Soc Clin Oncol

    (2003)
  • TL Winton et al.

    A prospective randomized trial of adjuvant vinorelbine and cisplatin in completely resected stage IB and II non-small cell lung cancer Intergroup JBR. 10 [abstract].

    Proc Am Soc Clin Oncol

    (2004)
  • GM Strauss et al.

    Randomized clinical trial of adjuvant chemotherapy with paclitaxel and carboplatin following resection in stage IB non-small-cell lung cancer: report of the Cancer and Leukemia Group B protocol 9633 [abstract].

    Proc Am Soc Clin Oncol

    (2004)
  • P Therasse et al.

    New guidelines to evaluate the response to treatment in solid tumors: European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada.

    J Natl Cancer Inst

    (2000)
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    This work was support by grants from Glaxo-Smith-Kline to Dr. Ramnath and Eli Lilly to Dr. Bepler.

    Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).

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