Coping with toxicities of docetaxel (TaxotereTM)

Schrijvers, Dorien M.; Wanders, J.; Dirix, Luc; Prové, A.; Vonck, I.; Oosterom, Allan Van; Kaye, Stanley B.

doi:10.1093/oxfordjournals.annonc.a058599

Cited by 137 publications

(60 citation statements)

References 2 publications

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“…Other side-effects included asthenia, infrequent hypersensitivity reactions, skin reactions, nail changes, mild sensory neuropathy and fluid retention. The application of premedication consisting of corticosteroids has markedly reduced the incidence of hypersensitivity reactions (Schrijvers et al, 1993) and seems to decrease the severity of fluid retention . Therefore, most studies on docetaxel are now performed with standard corticosteroid premedication.…”

mentioning

confidence: 99%

Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours

Pronk

Schrijvers²,

Schellens³

et al. 1998

Br J Cancer

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Summary Docetaxel and ifosfamide have shown significant activity against a variety of solid tumours. This prompted a phase I trial on the combination of these drugs. This phase I study was performed to assess the feasibility of the combination, to determine the maximum tolerated dose (MTD) and the side effects, and to propose a safe schedule for further phase 11 studies. A total of 34 patients with a histologically confirmed solid tumour, who were not pretreated with taxanes or ifosfamide and who had received no more than one line of chemotherapy for advanced disease were entered into the study. Treatment consisted of docetaxel given as a 1-h infusion followed by ifosfamide as a 24-h infusion (schedule A), or ifosfamide followed by docetaxel (schedule B) every 3 weeks. Docetaxel doses ranged from 60 to 85 mg m-2 and ifosfamide doses from 2.5 to 5.0 g m-2. Granulocytopenia grade 3 and 4 were common (89%), short lasting and ifosfamide dose dependent. Febrile neutropenia and sepsis occurred in 17% and 2% of courses respectively. Non-haematological toxicities were mild to moderate and included alopecia, nausea, vomiting, mucositis, diarrhoea, sensory neuropathy, skin and nail toxicity and oedema. There did not appear to be any pharmacokinetic interaction between docetaxel and ifosfamide. One complete response (CR) (soft tissue sarcoma) and two partial responses (PRs) were documented. A dose of 75 mg m-2 of docetaxel combined with 5.0 g m-2 ifosfamide appeared to be manageable. Schedule A was advocated for further treatment.

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mentioning

confidence: 99%

Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours

Pronk

Schrijvers²,

Schellens³

et al. 1998

Br J Cancer

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“…There is now some evidence to suggest that prophylactic corticosteroid-based premedication for hypersensitivity reactions and peripheral oedema may be useful both in reducing the incidence and severity of these events (Schrijvers et al, 1993;Valero et al, 1994) and in delaying the onset of fluid retention. It is possible that this strategy in combination with docetaxel (100 mg m-2) will be preferable to a reduced docetaxel dosage schedule for improving the safety profile of this drug while retaining maximum response rates.…”

Section: Discussionmentioning

confidence: 99%

A multicentre phase II study of docetaxel 75 mg m-2 as first-line chemotherapy for patients with advanced breast cancer: report of the Clinical Screening Group of the EORTC

Dièras

Chevallier²,

Kerbrat³

et al. 1996

Br J Cancer

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Summary In this phase II study, 39 women (median age 51 years) with advanced breast cancer received docetaxel (75 mg m-2) intravenously over 1 h every 3 weeks as first-line chemotherapy for advanced disease, without routine premedication for hypersensitivity reactions. In 31 evaluable patients, an overall response rate of 52% (95% CI 33-70%) was achieved, including a complete response rate of 13%. The median time to first response was 12 weeks (range 3-35+), the median duration of response was 34 weeks (range 11 -42+) and the median time to progression was 24 weeks (range 0-42+). Docetaxel showed considerable activity in patients with visceral involvement (52% response), including lung (67%) and liver (44%) metastases. The safety profile was acceptable. Grade 4 neutropenia occurred in 82% of patients (53% of cycles); febrile neutropenia (grade 4 neutropenia with fever >38°C, requiring antibiotics) occurred in only three (7.7%) patients (1.4% of cycles) and none of these required hospitalisation. Acute adverse events were generally well tolerated, with only two grade 3 events and no grade 4 events reported. Despite no prophylactic premedication, the incidence of acute hypersensitivity reactions was only 13%. Fluid retention was widely experienced (72% of patients) but was severe in only five (12.8%) patients and was the reason for discontinuation of treatment in 16 patients.Nevertheless, patients were able to receive a median cumulative dose of approximately 592 mg m-2 before discontinuing treatment, and the syndrome was slowly reversible after treatment withdrawal. In conclusion, docetaxel, even at a dose of 75 mg m-2, is confirmed to be an active agent in breast cancer. Compared with an earlier study of first-line docetaxel at the usual dose of 100 mg -2, it appears that 75 mg m-2 produces a lower response rate (52% vs 68%), although this still compares favourably with that of doxorubicin monotherapy in a similar patient population (43%). This difference is particularly striking in subgroups of patients with particularly poor prognostic factors, such as liver metastases or involvement of more than two organs. The incidence of fluid retention appears to be similar at the two doses and it is likely that premedication with corticosteroids will be preferable to dose reduction for managing this adverse event.

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“…Docetaxel, a novel mitotic spindle poison that acts as a microtubule stabilizer, has only infrequently been associated with the development of pulmonary toxicity, that is usually of the type of hypersensitivity pneumonitis not meeting the criteria for NCPE [61,62]. Notably, a fluid retention syndrome is known to occur in as many as 20%-60% of nonpremedicated patients treated with the agent, but this is typically peripheral, with pleural effusions reported only occasionally [63][64][65]. Although no NCPE has been attributed to docetaxel as a single agent to date, several cases have been reported with its combination with gemcitabine and radiotherapy [8,66,67].…”

Section: Cytotoxic Drugsmentioning

confidence: 99%

Noncardiogenic Pulmonary Edema: An Unusual and Serious Complication of Anticancer Therapy

Briasoulis

Pavlidis

2001

The Oncologist

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Noncardiogenic pulmonary edema (NCPE) is a rare and less well-recognizable pulmonotoxic syndrome of anticancer therapy than pneumonitis/fibrosis. NCPE is a clinical syndrome characterized by simultaneous presence of severe hypoxemia, bilateral alveolar infiltrates on chest radiograph, and no evidence of left atrial hypertension/congestive heart failure. The diagnosis of drug-related NCPE relies upon documented exclusion of any infectious, metabolic, or cancer-related causes. The Oncologist 2001;6:153-161 www.TheOncologist.com Correspondence: Evangelos Briasoulis, M.D., Medical Oncology Department, Ioannina University, Ioannina, 45110, Greece. Telephone and Fax: 30-651-99394; e-mail: ebriasou@otenet.gr. Received August 15, 2000; accepted for publication November 30, 2000. ©AlphaMed Press 1083-7159/2001 INTRODUCTIONSeveral cancer therapeutic drugs are known to induce pulmonary damage, which may result in a variety of clinicopathologic syndromes with minor to severe clinical consequences [1]. Clinical syndromes associated with drug-induced pulmonary toxicity include pneumonitis/fibrosis, hypersensitivity lung disease, and noncardiogenic pulmonary edema (NCPE)/acute respiratory distress syndrome (ARDS). These syndromes share a similar symptomatology but differ in regard to the time-relation to cancer treatment, the radiographic findings, the duration of pulmonary damage, and the long-term outcome [2]. Non-specific symptomatology of cough, progressive dyspnea, and often a low-grade fever alert clinicians confronted with the diagnostic challenge to recognize subclinical syndromes and differentiate fully developed drug-induced pulmonary reactions from lung injuries caused by infectious, cardiac, and neoplastic causes.

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Coping with toxicities of docetaxel (TaxotereTM)

Abstract: The acute hypersensitivity reaction could be completely blocked in all but in 1 of 14 patients, and this pretreatment schedule had an important prophylactic effect on edema formation. Skin toxicity was successfully treated with an ointment of glycerin and chlorhexidine.

Cited by 137 publications

References 2 publications

Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours

Phase I study on docetaxel and ifosfamide in patients with advanced solid tumours

A multicentre phase II study of docetaxel 75 mg m-2 as first-line chemotherapy for patients with advanced breast cancer: report of the Clinical Screening Group of the EORTC

Noncardiogenic Pulmonary Edema: An Unusual and Serious Complication of Anticancer Therapy

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