Combined cisplatin, doxorubicin, and mitomycin for the treatment of advanced pleural mesothelioma

A Phase II FONICAP trial

Maria Cristina Pennucci, Andrea Ardizzoni, Paolo Pronzato, Marina Fioretti, Claudio Lanfranco, Anna Verna, Guglielmina Giorgi, Antonella Vigani, Carlo Frola, Riccardo Rosso

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

BACKGROUND. In a previous FONICAP trial, the combination of doxorubicin (D) and cisplatin (P) yielded an objective response rate of 25% and a subjective response rate of 50% in patterns with mesothelioma. In human mesothelioma cell lines, mitomycin (M) showed a synergic activity with P and in a recent randomized study, the combination of M and P showed slightly superior activity when compared with the PD regimen. METHODS. The authors tested the activity and toxicity of a combination chemotherapy regimen including P, 60 mg/m2, D, 60 mg/m2, and M, 10 mg/m2, all by intravenous infusion on Day 1 every 28 days in a Phase II study. RESULTS. Twenty-four chemotherapy-naive mesothelioma patients were enrolled in the study. Patient characteristics were the following: the median age was 58 years; the median performance status was 1; there were 6 Stage 1 patients, 15 Stage II patients, 2 Stage III patients, and I Stage IV patient; and 10 patients had previous asbestos exposure. All patients had pretreatment symptoms: 13 had chest pain, 9 had pleural effusion, and 7 had dyspnea. A total of 78 cycles of chemotherapy were administered. The only significant side effect was myelosuppression, with only 9.5% of patients having Grade 4 toxicity. Among 23 patients evaluable for response, 5 achieved a partial response (20.8%; 95% confidence interval, 7.1-42.1%), 9 had stable disease, and 9 had progressive disease (including 1 early death). One patient was not evaluable because of treatment refusal. A clinical improvement was observed in 7 of 24 patients (29%). CONCLUSIONS. The combination of PDM in patients with pleural mesothelioma is feasible and moderately active. However, the observed level of activity is similar to that obtained with other two-drug regimens.

Original languageEnglish
Pages (from-to)1897-1902
Number of pages6
JournalCancer
Volume79
Issue number10
DOIs
Publication statusPublished - May 15 1997

Fingerprint

Mesothelioma
Mitomycin
Doxorubicin
Cisplatin
Therapeutics
Treatment Refusal
Drug Therapy
Asbestos
Pleural Effusion
Combination Drug Therapy
Chest Pain
Intravenous Infusions
Dyspnea

Keywords

  • chemotherapy
  • cisplatin
  • doxorubicin
  • mitomycin
  • pleural mesothelioma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Combined cisplatin, doxorubicin, and mitomycin for the treatment of advanced pleural mesothelioma : A Phase II FONICAP trial. / Pennucci, Maria Cristina; Ardizzoni, Andrea; Pronzato, Paolo; Fioretti, Marina; Lanfranco, Claudio; Verna, Anna; Giorgi, Guglielmina; Vigani, Antonella; Frola, Carlo; Rosso, Riccardo.

In: Cancer, Vol. 79, No. 10, 15.05.1997, p. 1897-1902.

Research output: Contribution to journalArticle

Pennucci, MC, Ardizzoni, A, Pronzato, P, Fioretti, M, Lanfranco, C, Verna, A, Giorgi, G, Vigani, A, Frola, C & Rosso, R 1997, 'Combined cisplatin, doxorubicin, and mitomycin for the treatment of advanced pleural mesothelioma: A Phase II FONICAP trial', Cancer, vol. 79, no. 10, pp. 1897-1902. https://doi.org/10.1002/(SICI)1097-0142(19970515)79:10<1897::AID-CNCR9>3.0.CO;2-D
Pennucci, Maria Cristina ; Ardizzoni, Andrea ; Pronzato, Paolo ; Fioretti, Marina ; Lanfranco, Claudio ; Verna, Anna ; Giorgi, Guglielmina ; Vigani, Antonella ; Frola, Carlo ; Rosso, Riccardo. / Combined cisplatin, doxorubicin, and mitomycin for the treatment of advanced pleural mesothelioma : A Phase II FONICAP trial. In: Cancer. 1997 ; Vol. 79, No. 10. pp. 1897-1902.
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abstract = "BACKGROUND. In a previous FONICAP trial, the combination of doxorubicin (D) and cisplatin (P) yielded an objective response rate of 25{\%} and a subjective response rate of 50{\%} in patterns with mesothelioma. In human mesothelioma cell lines, mitomycin (M) showed a synergic activity with P and in a recent randomized study, the combination of M and P showed slightly superior activity when compared with the PD regimen. METHODS. The authors tested the activity and toxicity of a combination chemotherapy regimen including P, 60 mg/m2, D, 60 mg/m2, and M, 10 mg/m2, all by intravenous infusion on Day 1 every 28 days in a Phase II study. RESULTS. Twenty-four chemotherapy-naive mesothelioma patients were enrolled in the study. Patient characteristics were the following: the median age was 58 years; the median performance status was 1; there were 6 Stage 1 patients, 15 Stage II patients, 2 Stage III patients, and I Stage IV patient; and 10 patients had previous asbestos exposure. All patients had pretreatment symptoms: 13 had chest pain, 9 had pleural effusion, and 7 had dyspnea. A total of 78 cycles of chemotherapy were administered. The only significant side effect was myelosuppression, with only 9.5{\%} of patients having Grade 4 toxicity. Among 23 patients evaluable for response, 5 achieved a partial response (20.8{\%}; 95{\%} confidence interval, 7.1-42.1{\%}), 9 had stable disease, and 9 had progressive disease (including 1 early death). One patient was not evaluable because of treatment refusal. A clinical improvement was observed in 7 of 24 patients (29{\%}). CONCLUSIONS. The combination of PDM in patients with pleural mesothelioma is feasible and moderately active. However, the observed level of activity is similar to that obtained with other two-drug regimens.",
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T1 - Combined cisplatin, doxorubicin, and mitomycin for the treatment of advanced pleural mesothelioma

T2 - A Phase II FONICAP trial

AU - Pennucci, Maria Cristina

AU - Ardizzoni, Andrea

AU - Pronzato, Paolo

AU - Fioretti, Marina

AU - Lanfranco, Claudio

AU - Verna, Anna

AU - Giorgi, Guglielmina

AU - Vigani, Antonella

AU - Frola, Carlo

AU - Rosso, Riccardo

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N2 - BACKGROUND. In a previous FONICAP trial, the combination of doxorubicin (D) and cisplatin (P) yielded an objective response rate of 25% and a subjective response rate of 50% in patterns with mesothelioma. In human mesothelioma cell lines, mitomycin (M) showed a synergic activity with P and in a recent randomized study, the combination of M and P showed slightly superior activity when compared with the PD regimen. METHODS. The authors tested the activity and toxicity of a combination chemotherapy regimen including P, 60 mg/m2, D, 60 mg/m2, and M, 10 mg/m2, all by intravenous infusion on Day 1 every 28 days in a Phase II study. RESULTS. Twenty-four chemotherapy-naive mesothelioma patients were enrolled in the study. Patient characteristics were the following: the median age was 58 years; the median performance status was 1; there were 6 Stage 1 patients, 15 Stage II patients, 2 Stage III patients, and I Stage IV patient; and 10 patients had previous asbestos exposure. All patients had pretreatment symptoms: 13 had chest pain, 9 had pleural effusion, and 7 had dyspnea. A total of 78 cycles of chemotherapy were administered. The only significant side effect was myelosuppression, with only 9.5% of patients having Grade 4 toxicity. Among 23 patients evaluable for response, 5 achieved a partial response (20.8%; 95% confidence interval, 7.1-42.1%), 9 had stable disease, and 9 had progressive disease (including 1 early death). One patient was not evaluable because of treatment refusal. A clinical improvement was observed in 7 of 24 patients (29%). CONCLUSIONS. The combination of PDM in patients with pleural mesothelioma is feasible and moderately active. However, the observed level of activity is similar to that obtained with other two-drug regimens.

AB - BACKGROUND. In a previous FONICAP trial, the combination of doxorubicin (D) and cisplatin (P) yielded an objective response rate of 25% and a subjective response rate of 50% in patterns with mesothelioma. In human mesothelioma cell lines, mitomycin (M) showed a synergic activity with P and in a recent randomized study, the combination of M and P showed slightly superior activity when compared with the PD regimen. METHODS. The authors tested the activity and toxicity of a combination chemotherapy regimen including P, 60 mg/m2, D, 60 mg/m2, and M, 10 mg/m2, all by intravenous infusion on Day 1 every 28 days in a Phase II study. RESULTS. Twenty-four chemotherapy-naive mesothelioma patients were enrolled in the study. Patient characteristics were the following: the median age was 58 years; the median performance status was 1; there were 6 Stage 1 patients, 15 Stage II patients, 2 Stage III patients, and I Stage IV patient; and 10 patients had previous asbestos exposure. All patients had pretreatment symptoms: 13 had chest pain, 9 had pleural effusion, and 7 had dyspnea. A total of 78 cycles of chemotherapy were administered. The only significant side effect was myelosuppression, with only 9.5% of patients having Grade 4 toxicity. Among 23 patients evaluable for response, 5 achieved a partial response (20.8%; 95% confidence interval, 7.1-42.1%), 9 had stable disease, and 9 had progressive disease (including 1 early death). One patient was not evaluable because of treatment refusal. A clinical improvement was observed in 7 of 24 patients (29%). CONCLUSIONS. The combination of PDM in patients with pleural mesothelioma is feasible and moderately active. However, the observed level of activity is similar to that obtained with other two-drug regimens.

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