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BACKGROUND

Updated survival analysis of JBR.10: A randomized phase III trial of vinorelbine/cisplatin versus observation in completely resected stage IB and II non-small cell lung cancer (NSCLC).

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BACKGROUND

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  1. Updated survival analysis of JBR.10: A randomized phase III trial of vinorelbine/cisplatin versus observation in completely resected stage IB and II non-small cell lung cancer (NSCLC). Authors: M. D. Vincent, C. Butts, L. Seymour, K. Ding, B. Graham, P. Twumasi-Ankrah, D. Gandara, J. Schiller, M. Green, F. Shepherd; London Regional Cancer Program, London, ON, Canada; Cross Cancer Centre, Edmonton, AB, Canada; NCIC Clinical Trials Group, Kingston, ON, Canada; UC Davis Cancer Centre, Sacremento, CA; Simmons Comprehensive Cancer Center, Dallas, TX; NMCR, Atlanta, GA; Princess Margaret Hospital, Toronto, ON, Canada Reviewed by: Dr. Charles Butts Posted: June 2009

  2. BACKGROUND • JBR.10 was one of the pivotal trials establishing adjuvant chemotherapy as standard of care in resected NSCLC. • This study is an update of survival with more than 9 years of follow-up.

  3. Stage IB or II NSCLC Complete resection Treatment A: Observation R Treatment B: Cisplatin + vinorelbine adjuvant chemotherapy • Nodal status • N0 • N1 • Ras mutation • Positive • Negative • unknown

  4. IMPORTANT DEMOGRAPHICS

  5. RESULTS

  6. OTHER RESULTS • Stage IB patients with primary tumor < 4 cm had no benefit. • Stage IB patients with primary tumor >/= 4 appeared to benefit (not stat sig) • No increase in non-cancer deaths in chemo arm. • No increase in second malignancies in chemo arm.

  7. STUDY COMMENTARY • Important to provide long-term follow-up to confirm persistent benefit of adjuvant chemo and any late toxicities • Longest follow-up of any of the phase III adjuvant trials. • Confirms benefit of chemotherapy for stage II patients. • No benefit in stage IB patients overall. • Post-hoc analysis of IB patients based on size showed similar results as the CALGB trial (size >/= 4cm nay predict those who benefit).

  8. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • Adjuvant chemotherapy for stage II patients results improvement in survival that are sustained. • There were no concerns for long term toxicities. • Stage IB patients with primary >/= 4 cm should continue to be considered for adjuvant therapy.

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