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 language | English |
|---|---|
| Pages (from-to) | 177-182 |
| Number of pages | 6 |
| Journal | Tumori |
| Volume | 85 |
| Issue number | 3 |
| Publication status | Published - May 1999 |
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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 journal › Article
}
TY - JOUR
T1 - The role of vindesine and lonidamine in the treatment of elderly patients with advanced non-small cell lung cancer
T2 - A phase III randomized fonicap trial
AU - De Marinis, Filippo
AU - Rinaldi, Massimo
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
PY - 1999/5
Y1 - 1999/5
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.
AB - 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.
KW - Chemotherapy
KW - Elderly patients
KW - Non-small cell lung cancer
KW - NSCLC
UR - http://www.scopus.com/inward/record.url?scp=0032813958&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0032813958&partnerID=8YFLogxK
M3 - Article
C2 - 10426128
AN - SCOPUS:0032813958
VL - 85
SP - 177
EP - 182
JO - Tumori
JF - Tumori
SN - 0300-8916
IS - 3
ER -