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Case History

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Image not available. A 69-year-old man is referred by a thoracic surgeon following complete resection of T2 N1 squamous cell carcinoma of the lung. Resection margins are clear.

What trials form the evidence base for adjuvant chemotherapy in this situation?

What factors would you take into account when deciding whether to offer this patient adjuvant chemotherapy?

What will you tell the patient?

If you and the patient decide that chemotherapy should be given, what regimen(s) and duration would you choose and why?

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Background

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What trials form the evidence base for adjuvant chemotherapy in this situation?

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Image not available. In 1995, a meta-analysis of updated data from 52 randomized clinical trials (1394 patients) indicated that adjuvant chemotherapy in surgically resected stage IB, II and IIIA non-small cell lung cancer (NSCLC) did not appreciably improve overall survival. There was, however, a trend in favour of chemotherapy regimens that included cisplatin. This analysis led to the development of several subsequent adjuvant chemotherapy trials with improved patient selection and refined drug regimens.

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The International Adjuvant Lung Cancer Trial (IALT) showed that adjuvant cisplatin-based chemotherapy improved relapse-free survival by 5.1% and overall survival by 4.1% at 5 years. The IALT included 1867 patients and investigated stage IA-IIIA disease, comparing three or four cycles of adjuvant combination chemotherapy including cisplatin combined with either etoposide, vinorelbine, vinblastine or vindesine, against observation.1 The National Cancer Institute of Canada (NCIC) JBR.10 trial showed a 15% improvement in overall survival in the chemotherapy-treated group at 5 years. This trial included 482 patients and investigated stage IB-II disease, comparing four cycles of a combination of vinorelbine and cisplatin against observation.2 The Adjuvant Navelbine International Trialist Association (ANITA) trial (including 840 patients, again comparing a combination of vinorelbine and cisplatin against observation in patients with stage IB-IIIA disease) showed an improvement in overall survival of 8.6% at 5 years, maintained at 7 years.3

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On the other hand, early reports of the Cancer and Leukaemia Group B (CALGB) 9633 trial indicated a marked 12% improvement in overall survival, but a 2006 update showed only a non-significant trend in favour of treatment at 5 years. That trial included 344 patients with stage IB disease only, comparing four cycles of a combination of paclitaxel and carboplatin against observation. The Adjuvant Lung Cancer Project Italy (ALPI) study also found no significant difference between adjuvant cisplatin-based chemotherapy and observation in completely resected NSCLC.

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However, the Lung Adjuvant Cisplatin Evaluation (LACE) meta-analysis concluded there was benefit of adjuvant cisplatin-based chemotherapy - of the order of 5%. In keeping with the updated CALGB results, the LACE meta-analysis failed to substantiate benefit in stage IB patients.4

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Discussion

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What factors would you take into account when deciding whether to offer this patient adjuvant chemotherapy?

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Image not available. The main curative therapeutic approach for stage IA-IIB NSCLC ...

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