Gemcitabine for malignant mesothelioma: A phase II trial by the Cancer and Leukemia Group B

Kindler, Hedy L.; Millard, Frederick E.; Herndon, James E.; Vogelzang, Nicholas J.; Suzuki, Yasunosuke; Green, Mark R.

doi:10.1016/s0169-5002(00)00166-5

Cited by 110 publications

(56 citation statements)

References 23 publications

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“…This 3-weekly schedule was given with manageable toxicity. The observed response rate is in keeping with the one reported in most cisplatin-based chemotherapy studies in malignant mesothelioma and with the ones reported in studies with cisplatin and gemcitabine as single agents (Mintzer et al, 1985;Zidar et al, 1988;Ong and Vogelzang, 1996;Van Meerbeeck et al, 1999;Kindler et al, 2001). In a single-institution study of mesothelioma, based on a four weekly regimen of cisplatin and gemcitabine in malignant mesothelioma, a response rate of 48% with a median survival of 9.5 months and an estimated 1 year survival of 41% was observed (Byrne et al, 1999).…”

Section: Discussionsupporting

confidence: 87%

“…The combination of cisplatin and gemcitabine was reported to be synergistic in terms of cytotoxicity, both in vitro and in vivo (Peters et al, 1995). Used as single agents response rates of cisplatin and gemcitabine in malignant mesothelioma have been reported of 13 -14% and 7 -24% respectively (Mintzer et al, 1985;Zidar et al, 1988;Van Meerbeeck et al, 1999;Kindler et al, 2001). Recently, an objective response rate of 48% has been reported with the combination of cisplatin and gemcitabine in malignant mesothelioma in a single institution study (Byrne et al, 1999).…”

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confidence: 99%

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Multicentre phase II study of gemcitabine and cisplatin in malignant pleural mesothelioma

Haarst¹,

Baas

Manegold³

et al. 2002

Br J Cancer

131

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Malignant pleural mesothelioma is a notoriously chemoresistant tumour. However, a recent single institution study showed an impressive activity of gemcitabine and cisplatin. Our aim is to investigate the efficacy and toxicity of a gemcitabine and cisplatin combination in selected and chemo-naive patients with histologically proven malignant pleural mesothelioma. Method: Gemcitabine 1250 mg m 72 was administered on day 1 and day 8 and cisplatin 80 mg m 72 was administered on day 1 in a 3-week cycle with a maximum of six cycles. Response and toxicity evaluations were performed according to WHO and NCIC-CTC criteria. Pathology and radiology were centrally reviewed. Results show that in 25 evaluable patients, four PR were observed (ORR 16%, 95% CI 1 -31%). Responses of seven patients were unevaluable. No unexpected toxicity occurred. Time to progression was 6 months (5 -7 months) with a median survival from registration of 9.6 months (95% CI 8 -12 months). In conclusion this trial excludes with 90% power a response rate of greater than 30% in patients with malignant pleural mesothelioma using a combination of gemcitabine and cisplatin at the proposed dose and schedule.

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Section: Discussionsupporting

confidence: 87%

mentioning

confidence: 99%

Multicentre phase II study of gemcitabine and cisplatin in malignant pleural mesothelioma

Haarst¹,

Baas

Manegold³

et al. 2002

Br J Cancer

131

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“…The activity of single-agent irinotecan (125 mg m À2 given weekly for 4 weeks, every 6 weeks) in malignant mesothelioma was investigated by the CALGB (Kindler et al, 2000). In 28 patients evaluable for analysis, no complete or partial responses were observed and the median overall survival was 7.9 months, indicating that irinotecan, at least in this dose and schedule, had no antitumor activity and considerable toxicity (leucopenia, neutropenia, diarrhoea).…”

Section: Camptothecin Analoguesmentioning

confidence: 99%

Chemotherapy for malignant pleural mesothelioma: past results and recent developments

Tomek

Manegold

2004

Lung Cancer

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This review summarises the results of previously conducted clinical trials, and subsequently presents data arising from all phase II -III studies on chemotherapy of malignant pleural mesothelioma (MPM) published since the last relevant overview. While response rates exceeding 30% have barely been achieved with established cytotoxic drugs in MPM therapy, novel chemotherapeutic agents and their combinations appear more promising. This applies especially to the antimetabolites, and in particular to pemetrexed that produced response rates of up to 45% in combination with platinum compounds. Raltitrexed combined with oxaliplatin has also been shown to be effective, and gemcitabine -applied as a single agent or in combination with cisplatin -as well as vinorelbine appear to improve the quality of life in patients presenting with MPM. Data can now be more precisely analysed by increasingly implemented randomised studies, applying a standardised staging system, and distinguishing prognostic groups. While chemotherapy for MPM remains a challenging task, important steps have clearly been made in the past years to combat this aggressive disease. The publication of pemetrexed with cisplatin phase III results in a peer-reviewed journal may soon establish a standard of care.

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“…There were no responses with singleagent CPT-11 in a phase II trial of the CALGB [15]. CPT-11 is converted to its more active metabolite, SN-38, which has 1,000 times the potency of the parent compound.…”

Section: Asbestos Consumption and Mesothelioma In Japanmentioning

confidence: 99%

Current therapies for malignant pleural mesothelioma

Nakano

2008

Environ Health Prev Med

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Mesothelioma is a highly lethal tumor derived from mesothelial cells, and its global incidence is increasing because of widespread exposure of numerous individuals to asbestos in the last 50 years. Mesothelioma is largely untreatable with any of the therapeutic modalities. Recently, a novel multitargeted antifolate pemetrexed has shown promising activity against malignant pleural mesothelioma, producing response rates of up to 40% when used in combination with cisplatin. In a large phase III study, use of a combination of pemetrexed and cisplatin was associated with significantly improved survival time and with greater antitumor activity compared with cisplatin alone. This combination also gave a significant response rate of approximately 50% in patients with epithelioid malignant pleural mesothelioma. These clinical benefits of pemetrexed-cisplatin doublet have changed the perception of mesothelioma chemotherapy. Other combinations, including gemcitabine in combination with cisplatin, have also shown encouraging response rates. Prognosis depends on gender, clinical stage of the tumor, histological subtype, platelet count, leukocyte counts, and performance status. Radiotherapy can palliate mesothelioma patients with chest pain, and has been indicated to be of benefit for the prevention of malignant seeding along the tract of a chest tube or needle biopsy. Trimodality treatment using extrapleural pneumonectomy, radiation and chemotherapy has shown promising therapeutic value. The development of chemotherapeutic regimens and the favorable outcomes of trimodality have led to new combined modality trials. In Japan, multicenter national trials against mesothelioma will begin in the near future.

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Gemcitabine for malignant mesothelioma: A phase II trial by the Cancer and Leukemia Group B

Abstract: No antitumor activity was observed for single-agent gemcitabine in patients with malignant mesothelioma in this multicenter phase II study.

Cited by 110 publications

References 23 publications

Multicentre phase II study of gemcitabine and cisplatin in malignant pleural mesothelioma

Multicentre phase II study of gemcitabine and cisplatin in malignant pleural mesothelioma

Chemotherapy for malignant pleural mesothelioma: past results and recent developments

Current therapies for malignant pleural mesothelioma

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