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

C. Gridelli, C. Gallo, M. Di Maio, E. Barletta, A. Illiano, P. Maione, S. Salvagni, F. V. Piantedosi, G. Palazzolo, O. Caffo, A. Ceribelli, A. Falcone, P. Mazzanti, L. Brancaccio, M. A. Capuano, L. Isa, S. Barbera, F. Perrone

Research output: Contribution to journalArticle

143 Citations (Scopus)

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, ≤75 years, ECOG PS ≤2. 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.

Original languageEnglish
Pages (from-to)1996-2004
Number of pages9
JournalBritish Journal of Cancer
Volume91
Issue number12
DOIs
Publication statusPublished - Dec 13 2004

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docetaxel
Non-Small Cell Lung Carcinoma
Randomized Controlled Trials
Quality of Life
Appointments and Schedules
Alopecia
Appetite
Febrile Neutropenia
Poisons
Leukopenia
Therapeutics
Neutropenia
Cough
Nausea
Diarrhea
Survival Rate
Pain
Survival

Keywords

  • Advanced NSCLC
  • Docetaxel
  • Quality of life
  • Second line
  • Weekly schedule

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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. / Gridelli, C.; Gallo, C.; Di Maio, M.; Barletta, E.; Illiano, A.; Maione, P.; Salvagni, S.; Piantedosi, F. V.; Palazzolo, G.; Caffo, O.; Ceribelli, A.; Falcone, A.; Mazzanti, P.; Brancaccio, L.; Capuano, M. A.; Isa, L.; Barbera, S.; Perrone, F.

In: British Journal of Cancer, Vol. 91, No. 12, 13.12.2004, p. 1996-2004.

Research output: Contribution to journalArticle

Gridelli, C, Gallo, C, Di Maio, M, Barletta, E, Illiano, A, Maione, P, Salvagni, S, Piantedosi, FV, Palazzolo, G, Caffo, O, Ceribelli, A, Falcone, A, Mazzanti, P, Brancaccio, L, Capuano, MA, Isa, L, Barbera, S & Perrone, F 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', British Journal of Cancer, vol. 91, no. 12, pp. 1996-2004. https://doi.org/10.1038/sj.bjc.6602241
Gridelli, C. ; Gallo, C. ; Di Maio, M. ; Barletta, E. ; Illiano, A. ; Maione, P. ; Salvagni, S. ; Piantedosi, F. V. ; Palazzolo, G. ; Caffo, O. ; Ceribelli, A. ; Falcone, A. ; Mazzanti, P. ; Brancaccio, L. ; Capuano, M. A. ; Isa, L. ; Barbera, S. ; Perrone, F. / 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. In: British Journal of Cancer. 2004 ; Vol. 91, No. 12. pp. 1996-2004.
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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, ≤75 years, ECOG PS ≤2. 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.",
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AU - Maione, P.

AU - Salvagni, S.

AU - Piantedosi, F. V.

AU - Palazzolo, G.

AU - Caffo, O.

AU - Ceribelli, A.

AU - Falcone, A.

AU - Mazzanti, P.

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