Clinical

British Journal of Cancer (2004) 91, 1996–2004. doi:10.1038/sj.bjc.6602241 www.bjcancer.com
Published online 23 November 2004

A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study

See Appendix for a complete list of Coauthors and Institutions

C Gridelli1, C Gallo2, M Di Maio3, E Barletta4, A Illiano5, P Maione1, S Salvagni6, F V Piantedosi7, G Palazzolo8, O Caffo9, A Ceribelli10, A Falcone11, P Mazzanti12, L Brancaccio5, M A Capuano13, L Isa14, S Barbera15 and F Perrone3 on behalf of the DISTAL (Docetaxel In Second-line Treatment of Advanced Lung cancer) Investigators

  1. 1Oncologia Medica, Azienda Ospedaliera S Giuseppe Moscati, Avellino
  2. 2Statistica Medica, Seconda Università di Napoli
  3. 3Unità Operativa Sperimentazioni Cliniche, Istituto Nazionale Tumori, Napoli
  4. 4Oncologia Medica B, Istituto Nazionale Tumori, Napoli
  5. 5Pneumooncologia, II Divisione, Ospedale Monaldi, Napoli
  6. 6Oncologia, Ospedale Regionale, Parma
  7. 7Pneumooncologia, I Divisione, Ospedale Monaldi, Napoli
  8. 8Oncologia Medica, ULSS 15 Regione Veneto
  9. 9Oncologia Medica, Ospedale S Chiara, Trento
  10. 10Oncologia Medica A, Istituto Regina Elena, Roma
  11. 11Oncologia, Ospedali Riuniti, Livorno
  12. 12Oncologia Medica, Azienda Ospedaliera Umberto I, Torrette di Ancona
  13. 13Chirurgia Toracica, Ospedali Riuniti, Foggia
  14. 14Oncologia Medica, Ospedale Serbelloni, Gorgonzola
  15. 15Pneumologia, Ospedale Mariano Santo, Cosenza

Correspondence: C Gridelli, Clinical Trials Unit, National Cancer Institute, Via Mariano Semmola, 80131 Naples – Italy. E-mail: cgridelli@libero.it

Revised 8 September 2004; Accepted 30 September 2004; Published online 23 November 2004.

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Abstract

Docetaxel (75 mg m-2 3-weekly) is standard second-line treatment in advanced non-small-cell lung cancer (NSCLC) with significant toxicity. To verify whether a weekly schedule (33.3 mg m-2 for 6 weeks) improved quality of life (QoL), a phase III study was performed with 220 advanced NSCLC patients, less than or equal to75 years, ECOG PS less than or equal to2. QoL was assessed by EORTC questionnaires and the Daily Diary Card (DDC). No difference was found in global QoL scores at 3 weeks. Pain, cough and hair loss significantly favoured the weekly schedule, while diarrhoea was worse. DDC analysis showed that loss of appetite and overall condition were significantly worse in the 3-week arm in the first week, while nausea and loss of appetite were more severe in the weekly arm in the third week. Response rate and survival were similar, hazard ratio of death in the weekly arm being 1.04 (95% CI 0.77–1.39). A 3-weekly docetaxel was more toxic for leukopenia, neutropenia, febrile neutropenia and hair loss; any grade 3–4 haematologic toxicity was significantly more frequent in the standard arm (25 vs 6%). The weekly schedule could be preferred for patients candidate to receive docetaxel as second-line treatment for advanced NSCLC, because of some QoL advantages, lower toxicity and no evidence of strikingly different effect on survival.

Keywords:

quality of life, docetaxel, weekly schedule, second line, advanced NSCLC