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A pilot study of a day one and eight every three weeks administration of docetaxel in metastatic cancer patients.
| Content Provider | Semantic Scholar |
|---|---|
| Author | Martella, Francesca Giannessi, Pier Giorgio Marsico, Roberta Di Coltelli, Luigi Safina, Valentina Giuntini, Nicola Falcone, Alfredo |
| Copyright Year | 2007 |
| Abstract | AIMS AND BACKGROUND Docetaxel is an active agent in metastatic cancers. The standard administration every 3 weeks frequently causes gastrointestinal toxicity and severe myelosuppression. These are rare with a weekly docetaxel regimen, which instead produces severe asthenia. To develop a new docetaxel schedule associated with mild myelosuppression and less fatigue, we conducted this pilot study to determine the feasibility and the maximum tolerated dose of a day one and eight every three weeks administration of docetaxel. PATIENTS AND METHODS The first 3 patients were treated with a dose of 40 mg/m2 on day one and eight, which was then escalated by increments of 5 mg/m2 on both days up to determine the maximum tolerated dose, defined as the dose level associated with the same dose-limiting toxicity in at least 33% of patients. RESULTS Twenty-one metastatic cancer patients entered the study, with a median age of 57 years and a median performance status of 1. The escalation of dose continued up to 55 mg/m2, where 2 of the 6 enrolled patients presented grade 3 diarrhea, which was our dose-limiting toxicity. Myelosuppression was mild, and no febrile neutropenia was observed. None of the patients showed grade 4 non-haematological toxicity. Only 9.5% of them presented grade 3 asthenia, whereas grade 3 diarrhea and mucositis were revealed in 19% and 9.5%, respectively. All grade 3 non-hematological toxicities were observed in heavily pretreated or elderly patients. CONCLUSIONS The recommended dose of docetaxel was 50 mg/m2, but the regimen could not be recommended in heavily pretreated patients. However, it could become an option in an outpatient setting after a phase II study that better defines its toxicity profile and evaluate its antitumor activity. |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | http://vecchiosito.istitutotumori.mi.it/istituto/documenti/rivistatumori/2007_02/6-Martella(145-149).pdf |
| PubMed reference number | 17557560v1 |
| Volume Number | 93 |
| Issue Number | 2 |
| Journal | Tumori |
| Language | English |
| Access Restriction | Open |
| Subject Keyword | Adverse reaction to drug Asthenia Bone Marrow Diseases Diarrhea Escalation Fatigue Febrile Neutropenia Fever Gastrointestinal Diseases Inflammatory disease of mucous membrane Maximum Tolerated Dose Milligram per Square Meter Neoplasms Patients Status Epilepticus docetaxel |
| Content Type | Text |
| Resource Type | Article |
