A phase III randomised study of concomitant induction radiochemotherapy testing two modalities of radiosensitisation by cisplatin (standard versus daily) for limited small-cell lung cancer.

Abstract

BACKGROUND:

The purpose of this study was to determine in limited small-cell lung cancer if locoregional irradiation concurrently with induction chemotherapy with cisplatin and etoposide prolongs survival when cisplatin is given daily as a radiosensitiser.

PATIENTS AND METHODS:

Two-hundred and four eligible patients were randomised between standard radiosensitised induction chemoradiotherapy (arm A) with cisplatin (90 mg/m(2) day 1) plus etoposide and daily radiosensitised induction chemoradiotherapy (arm B) with cisplatin (6 mg/m(2)/day) plus etoposide. Chemotherapy and chest irradiation (39.90 Gy in 15 fractions >3 weeks) both started on day 1.

RESULTS:

There was no difference in survival between both arms with respective median, 2 and 5 years of 15.5 months, 35% and 18% in arm A and 17.0 months, 38% and 21% in arm B (P = 0.50). Performance status and T status were identified as independent prognostic factors for survival. In terms of local control rate, there was a statistical trend in favour of arm A with 2% only local relapse versus 10% in arm B. Daily cisplatin radiosensitisation was associated with more oesophagitis and thrombopenia but less nephrotoxicity.

CONCLUSION:

Induction chemoradiotherapy resulted in both arms in good long-term survival, comparable to the best reported results and without improvement by daily cisplatin administration.

• Authors: J P Sculier, J J Lafitte, A Efremidis, M C Florin, J Lecomte, M C Berchier, M Richez, T Berghmans, A Scherpereel, A P Meert, G Koumakis, N Leclercq, M Paesmans, P Van Houtte, European Lung Cancer Working Party (ELCWP)
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 19 Issue 10 Pg. 1691-7 (Oct 2008) ISSN: 1569-8041 [Electronic] England
• PMID: 18504252 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Radiation-Sensitizing Agents
• Etoposide
• Cisplatin

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Carcinoma, Small Cell (drug therapy, radiotherapy)
• Cisplatin (administration & dosage, adverse effects)
• Combined Modality Therapy
• Disease-Free Survival
• Drug Administration Schedule
• Etoposide (administration & dosage, adverse effects)
• Female
• Humans
• Lung Neoplasms (drug therapy, radiotherapy)
• Male
• Middle Aged
• Radiation-Sensitizing Agents (administration & dosage, adverse effects)