Abstract
Purpose: We performed a multicenter phase II trial to evaluate the impact on the activity, efficacy, symptom control and safety of using two active regimens in a sequential schedule (cisplatin/gemcitabine followed by mitoxantrone/methotrexate/mitomycin) as first-line chemotherapy for unresectable malignant pleural mesothelioma (MPM). Patients and methods: A total of 54 patients received cisplatin 75 mg/m2 on day 1 and gemcitabine 1200 mg/m2 on days 1 and 8, every 3 weeks for four courses (CG regimen) followed by mitoxantrone 10 mg/m2 on day 1, methotrexate 35 mg/m2 on day 1 and mitomycin 7 mg/m2 on day 1, every 3 weeks with mitomycin in alternate cycles for four courses (MMM regimen). Results: We observed 3 complete responses (CRs) (5.6%) and 13 partial responses (PRs) (24.0%), with an overall response rate (ORR) of 29.6% (95% confidence interval, 17-42%), 33 stable disease (SD) (61.1%) and 5 progressive disease (PD) (9.2%). Median time to progression (TTP) was 9.5 months (range, 2-23). Median overall survival (OS) was 13 months (range, 3-33); 1-year survival rate was 63%. The treatment produced a good symptom control, with an improvement during chemotherapy in dyspnea and pain in 52.9 and 48.3% of patients, respectively. The major toxicity observed was hematological. Grades 3-4 NCI-CTC v 2.0 toxicity with the CG regimen included: neutropenia (11.1%), anemia (1.9%), thrombocytopenia (7.4%), vomiting (11.1%) and with the MMM regimen: neutropenia (35.2%), anemia (5.5%), thrombocytopenia (7.4%) and stomatitis (1.9%). Conclusion: This phase II study with the sequential approach of two active regimens showed a good disease control in MPM, with symptom improvement and only mild toxicity.
| Original language | English |
|---|---|
| Pages (from-to) | 199-206 |
| Number of pages | 8 |
| Journal | Lung Cancer |
| Volume | 52 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - May 2006 |
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Keywords
- Cisplatin/gemcitabine
- Mitoxantrone/methotrexate/mitomycin
- Phase II study
ASJC Scopus subject areas
- Oncology
Cite this
Sequential chemotherapy with cisplatin/gemcitabine (CG) followed by mitoxantrone/methotrexate/mitomycin (MMM) in patients with malignant pleural mesothelioma. A multicenter Italian Phase II Study (SITMP1). / Pinto, Carmine; Marino, Antonella; Manzini, Vincenzo De Pangher; Benedetti, Giovanni; Galetta, Domenico; Mazzanti, Paola; Del Conte, Guido; dell'Amore, Davide; Piana, Edera; Giaquinta, Stefania; Lopez, Massimo; Martoni, Andrea.
In: Lung Cancer, Vol. 52, No. 2, 05.2006, p. 199-206.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Sequential chemotherapy with cisplatin/gemcitabine (CG) followed by mitoxantrone/methotrexate/mitomycin (MMM) in patients with malignant pleural mesothelioma. A multicenter Italian Phase II Study (SITMP1)
AU - Pinto, Carmine
AU - Marino, Antonella
AU - Manzini, Vincenzo De Pangher
AU - Benedetti, Giovanni
AU - Galetta, Domenico
AU - Mazzanti, Paola
AU - Del Conte, Guido
AU - dell'Amore, Davide
AU - Piana, Edera
AU - Giaquinta, Stefania
AU - Lopez, Massimo
AU - Martoni, Andrea
PY - 2006/5
Y1 - 2006/5
N2 - Purpose: We performed a multicenter phase II trial to evaluate the impact on the activity, efficacy, symptom control and safety of using two active regimens in a sequential schedule (cisplatin/gemcitabine followed by mitoxantrone/methotrexate/mitomycin) as first-line chemotherapy for unresectable malignant pleural mesothelioma (MPM). Patients and methods: A total of 54 patients received cisplatin 75 mg/m2 on day 1 and gemcitabine 1200 mg/m2 on days 1 and 8, every 3 weeks for four courses (CG regimen) followed by mitoxantrone 10 mg/m2 on day 1, methotrexate 35 mg/m2 on day 1 and mitomycin 7 mg/m2 on day 1, every 3 weeks with mitomycin in alternate cycles for four courses (MMM regimen). Results: We observed 3 complete responses (CRs) (5.6%) and 13 partial responses (PRs) (24.0%), with an overall response rate (ORR) of 29.6% (95% confidence interval, 17-42%), 33 stable disease (SD) (61.1%) and 5 progressive disease (PD) (9.2%). Median time to progression (TTP) was 9.5 months (range, 2-23). Median overall survival (OS) was 13 months (range, 3-33); 1-year survival rate was 63%. The treatment produced a good symptom control, with an improvement during chemotherapy in dyspnea and pain in 52.9 and 48.3% of patients, respectively. The major toxicity observed was hematological. Grades 3-4 NCI-CTC v 2.0 toxicity with the CG regimen included: neutropenia (11.1%), anemia (1.9%), thrombocytopenia (7.4%), vomiting (11.1%) and with the MMM regimen: neutropenia (35.2%), anemia (5.5%), thrombocytopenia (7.4%) and stomatitis (1.9%). Conclusion: This phase II study with the sequential approach of two active regimens showed a good disease control in MPM, with symptom improvement and only mild toxicity.
AB - Purpose: We performed a multicenter phase II trial to evaluate the impact on the activity, efficacy, symptom control and safety of using two active regimens in a sequential schedule (cisplatin/gemcitabine followed by mitoxantrone/methotrexate/mitomycin) as first-line chemotherapy for unresectable malignant pleural mesothelioma (MPM). Patients and methods: A total of 54 patients received cisplatin 75 mg/m2 on day 1 and gemcitabine 1200 mg/m2 on days 1 and 8, every 3 weeks for four courses (CG regimen) followed by mitoxantrone 10 mg/m2 on day 1, methotrexate 35 mg/m2 on day 1 and mitomycin 7 mg/m2 on day 1, every 3 weeks with mitomycin in alternate cycles for four courses (MMM regimen). Results: We observed 3 complete responses (CRs) (5.6%) and 13 partial responses (PRs) (24.0%), with an overall response rate (ORR) of 29.6% (95% confidence interval, 17-42%), 33 stable disease (SD) (61.1%) and 5 progressive disease (PD) (9.2%). Median time to progression (TTP) was 9.5 months (range, 2-23). Median overall survival (OS) was 13 months (range, 3-33); 1-year survival rate was 63%. The treatment produced a good symptom control, with an improvement during chemotherapy in dyspnea and pain in 52.9 and 48.3% of patients, respectively. The major toxicity observed was hematological. Grades 3-4 NCI-CTC v 2.0 toxicity with the CG regimen included: neutropenia (11.1%), anemia (1.9%), thrombocytopenia (7.4%), vomiting (11.1%) and with the MMM regimen: neutropenia (35.2%), anemia (5.5%), thrombocytopenia (7.4%) and stomatitis (1.9%). Conclusion: This phase II study with the sequential approach of two active regimens showed a good disease control in MPM, with symptom improvement and only mild toxicity.
KW - Cisplatin/gemcitabine
KW - Mitoxantrone/methotrexate/mitomycin
KW - Phase II study
UR - http://www.scopus.com/inward/record.url?scp=33646002369&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33646002369&partnerID=8YFLogxK
U2 - 10.1016/j.lungcan.2006.01.002
DO - 10.1016/j.lungcan.2006.01.002
M3 - Article
C2 - 16542747
AN - SCOPUS:33646002369
VL - 52
SP - 199
EP - 206
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
IS - 2
ER -