The role of vindesine and lonidamine in the treatment of elderly patients with advanced non-small cell lung cancer: A phase III randomized fonicap trial

Filippo De Marinis, Massimo Rinaldi, Andrea Ardizzoni, Paolo Bruzzi, Maria Cristina Pennucci, Luigi Portalone, Modesto D'Aprile, Paola Ripanti, Francesco Romano, Massimo Belli, Giuseppe Altavilla, Maria Rita Migliorino, Riccardo Rosso, Franco Salvati

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Aims: To evaluate the efficacy and treatment compliance in elderly patients with advanced non-small cell lung cancer (NSCLC) of two chemotherapeutic agents with mild toxicity, 153 previously untreated patients aged over 70 years were randomized to receive lonidamine (450 mg daily p.o. until progression), vindesine (3 mg/m2/daily i.v. weekly for 4 weeks and then every 2 weeks until progression), the combination of the two drugs at the same dose and schedule, or supportive therapy only in a four-arm factorial randomized trial. Methods: 126 patients were included in the final analysis. Their median age was 75 years. Forty percent had stage IV disease and 60% stage III. Most patients were males (85%) and the majority had squamous histology (68%). Results: Among 104 patients evaluable for response there were only 3 PRs (1/30 in the lonidamine arm and 2/33 in the lonidamine + vindesine arm). Overall, 8.7% and 9.5% of the patients, respectively, progressed or died early, before response evaluation; another 9.4% refused treatment continuation because of poor compliance with the study protocol. Eighty-five patients were fully evaluable for toxicity, which was generally mild. Leukopenia grade 1-3 was found in less than 30% of patients treated with vindesine or vindesine + lonidamine. The most common complaints associated with lonidamine treatment were myalgia (70% of patients), fatigue (55% and 83% of patients treated with lonidamine or lonidamine + vindesine, respectively) and testicular pain in nearly 40% of cases. The overall median survival was 170 days, with no significant impact on survival of either lonidamine or vindesine. Conclusions: The low response rate and survival together with the poor treatment compliance, even in the presence of mild toxicity, do not support the usefulness of these 'gentle' chemotherapies in elderly NSCLC patients. The standard management of advanced NSCLC in elderly patients remains to be defined. Specifically designed studies to address this issue are warranted.

Original languageEnglish
Pages (from-to)177-182
Number of pages6
JournalTumori
Volume85
Issue number3
Publication statusPublished - May 1999

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Vindesine
Non-Small Cell Lung Carcinoma
Therapeutics
lonidamine
Survival
Myalgia
Leukopenia
Drug Combinations
Compliance
Fatigue

Keywords

  • Chemotherapy
  • Elderly patients
  • Non-small cell lung cancer
  • NSCLC

ASJC Scopus subject areas

  • Cancer Research

Cite this

The role of vindesine and lonidamine in the treatment of elderly patients with advanced non-small cell lung cancer : A phase III randomized fonicap trial. / De Marinis, Filippo; Rinaldi, Massimo; Ardizzoni, Andrea; Bruzzi, Paolo; Pennucci, Maria Cristina; Portalone, Luigi; D'Aprile, Modesto; Ripanti, Paola; Romano, Francesco; Belli, Massimo; Altavilla, Giuseppe; Migliorino, Maria Rita; Rosso, Riccardo; Salvati, Franco.

In: Tumori, Vol. 85, No. 3, 05.1999, p. 177-182.

Research output: Contribution to journalArticle

De Marinis, F, Rinaldi, M, Ardizzoni, A, Bruzzi, P, Pennucci, MC, Portalone, L, D'Aprile, M, Ripanti, P, Romano, F, Belli, M, Altavilla, G, Migliorino, MR, Rosso, R & Salvati, F 1999, 'The role of vindesine and lonidamine in the treatment of elderly patients with advanced non-small cell lung cancer: A phase III randomized fonicap trial', Tumori, vol. 85, no. 3, pp. 177-182.
De Marinis, Filippo ; Rinaldi, Massimo ; Ardizzoni, Andrea ; Bruzzi, Paolo ; Pennucci, Maria Cristina ; Portalone, Luigi ; D'Aprile, Modesto ; Ripanti, Paola ; Romano, Francesco ; Belli, Massimo ; Altavilla, Giuseppe ; Migliorino, Maria Rita ; Rosso, Riccardo ; Salvati, Franco. / The role of vindesine and lonidamine in the treatment of elderly patients with advanced non-small cell lung cancer : A phase III randomized fonicap trial. In: Tumori. 1999 ; Vol. 85, No. 3. pp. 177-182.
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abstract = "Aims: To evaluate the efficacy and treatment compliance in elderly patients with advanced non-small cell lung cancer (NSCLC) of two chemotherapeutic agents with mild toxicity, 153 previously untreated patients aged over 70 years were randomized to receive lonidamine (450 mg daily p.o. until progression), vindesine (3 mg/m2/daily i.v. weekly for 4 weeks and then every 2 weeks until progression), the combination of the two drugs at the same dose and schedule, or supportive therapy only in a four-arm factorial randomized trial. Methods: 126 patients were included in the final analysis. Their median age was 75 years. Forty percent had stage IV disease and 60{\%} stage III. Most patients were males (85{\%}) and the majority had squamous histology (68{\%}). Results: Among 104 patients evaluable for response there were only 3 PRs (1/30 in the lonidamine arm and 2/33 in the lonidamine + vindesine arm). Overall, 8.7{\%} and 9.5{\%} of the patients, respectively, progressed or died early, before response evaluation; another 9.4{\%} refused treatment continuation because of poor compliance with the study protocol. Eighty-five patients were fully evaluable for toxicity, which was generally mild. Leukopenia grade 1-3 was found in less than 30{\%} of patients treated with vindesine or vindesine + lonidamine. The most common complaints associated with lonidamine treatment were myalgia (70{\%} of patients), fatigue (55{\%} and 83{\%} of patients treated with lonidamine or lonidamine + vindesine, respectively) and testicular pain in nearly 40{\%} of cases. The overall median survival was 170 days, with no significant impact on survival of either lonidamine or vindesine. Conclusions: The low response rate and survival together with the poor treatment compliance, even in the presence of mild toxicity, do not support the usefulness of these 'gentle' chemotherapies in elderly NSCLC patients. The standard management of advanced NSCLC in elderly patients remains to be defined. Specifically designed studies to address this issue are warranted.",
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AU - Ardizzoni, Andrea

AU - Bruzzi, Paolo

AU - Pennucci, Maria Cristina

AU - Portalone, Luigi

AU - D'Aprile, Modesto

AU - Ripanti, Paola

AU - Romano, Francesco

AU - Belli, Massimo

AU - Altavilla, Giuseppe

AU - Migliorino, Maria Rita

AU - Rosso, Riccardo

AU - Salvati, Franco

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N2 - Aims: To evaluate the efficacy and treatment compliance in elderly patients with advanced non-small cell lung cancer (NSCLC) of two chemotherapeutic agents with mild toxicity, 153 previously untreated patients aged over 70 years were randomized to receive lonidamine (450 mg daily p.o. until progression), vindesine (3 mg/m2/daily i.v. weekly for 4 weeks and then every 2 weeks until progression), the combination of the two drugs at the same dose and schedule, or supportive therapy only in a four-arm factorial randomized trial. Methods: 126 patients were included in the final analysis. Their median age was 75 years. Forty percent had stage IV disease and 60% stage III. Most patients were males (85%) and the majority had squamous histology (68%). Results: Among 104 patients evaluable for response there were only 3 PRs (1/30 in the lonidamine arm and 2/33 in the lonidamine + vindesine arm). Overall, 8.7% and 9.5% of the patients, respectively, progressed or died early, before response evaluation; another 9.4% refused treatment continuation because of poor compliance with the study protocol. Eighty-five patients were fully evaluable for toxicity, which was generally mild. Leukopenia grade 1-3 was found in less than 30% of patients treated with vindesine or vindesine + lonidamine. The most common complaints associated with lonidamine treatment were myalgia (70% of patients), fatigue (55% and 83% of patients treated with lonidamine or lonidamine + vindesine, respectively) and testicular pain in nearly 40% of cases. The overall median survival was 170 days, with no significant impact on survival of either lonidamine or vindesine. Conclusions: The low response rate and survival together with the poor treatment compliance, even in the presence of mild toxicity, do not support the usefulness of these 'gentle' chemotherapies in elderly NSCLC patients. The standard management of advanced NSCLC in elderly patients remains to be defined. Specifically designed studies to address this issue are warranted.

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