High-dose chemotherapy regimen well tolerated in breast cancer

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Inpharma 1320 - 12 Jan 2002 High-dose chemotherapy regimen well tolerated in breast cancer A high-dose chemotherapy regimen comprising mitoxantrone plus cyclophosphamide without stem cell support is well tolerated in patients with metastatic or high-risk breast cancer, report researchers from Spain. In this phase II study, 53 such patients (median age 45 years) received 2 cycles of cyclophosphamide 4000 mg/m 2 plus mitoxantrone 25 mg/m 2 with a 4–6 week interval between cycles. * ; All patients received SC granulocyte colony-stimulating factor and antimicrobial prophylaxis with oral ciprofloxacin. A total of 101 treatment cycles were administered. 48 patients received the planned 2 treatment cycles with a median interval of 31 days between cycles. Haematological toxicity There were no treatment-related deaths and haematological toxicity was the most common adverse event. Platelet counts fell to < 20 000/mm 3 after 49% of treatment cycles with platelet transfusions required after 44% of cycles. Absolute neutrophil counts dropped to < 500/mm 3 after 84% of treatment cycles with a median recovery period of 11 days. Infectious complications developed after 46% of treatment cycles with febrile neutropenia being reported after 36 treatment cycles. The most common nonhaematological adverse events were emesis and mucositis. The researchers conclude that this high-dose regimen can be administered ‘safely’ without the need for haematopoietic stem cell support. * Patients with metastatic breast cancer had complete or partial response to standard chemotherapy or had no evidence of disease after surgery or radiotherapy. Patients with high-risk breast cancer had 5 positive axillary nodes or inflammatory breast carcinoma and had undergone surgery and conventional chemotherapy. † The study was supported by Wyeth-Lederle. erez-Gracia JL, et al. High-dose mitoxantrone and cyclophosphamide without stem cell support in patients with high-risk and advanced breast carcinoma: a phase II multicentric trial. Cancer 92: 2508-2516, 15 Nov 2001 800885995 1 Inpharma 12 Jan 2002 No. 1320 1173-8324/10/1320-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Transcript of High-dose chemotherapy regimen well tolerated in breast cancer

Inpharma 1320 - 12 Jan 2002

High-dose chemotherapy regimenwell tolerated in breast cancer

A high-dose chemotherapy regimen comprisingmitoxantrone plus cyclophosphamide without stem cellsupport is well tolerated in patients with metastatic orhigh-risk breast cancer, report researchers from Spain.

In this phase II study, 53 such patients (median age 45years) received 2 cycles of cyclophosphamide 4000mg/m2 plus mitoxantrone 25 mg/m2 with a 4–6 weekinterval between cycles.*;† All patients received SCgranulocyte colony-stimulating factor and antimicrobialprophylaxis with oral ciprofloxacin.

A total of 101 treatment cycles were administered. 48patients received the planned 2 treatment cycles with amedian interval of 31 days between cycles.

Haematological toxicityThere were no treatment-related deaths and

haematological toxicity was the most common adverseevent. Platelet counts fell to < 20 000/mm3 after 49% oftreatment cycles with platelet transfusions required after44% of cycles.

Absolute neutrophil counts dropped to < 500/mm3

after 84% of treatment cycles with a median recoveryperiod of 11 days. Infectious complications developedafter 46% of treatment cycles with febrile neutropeniabeing reported after 36 treatment cycles.

The most common nonhaematological adverse eventswere emesis and mucositis.

The researchers conclude that this high-dose regimencan be administered ‘safely’ without the need forhaematopoietic stem cell support.* Patients with metastatic breast cancer had complete or partialresponse to standard chemotherapy or had no evidence of diseaseafter surgery or radiotherapy. Patients with high-risk breast cancer had≥ 5 positive axillary nodes or inflammatory breast carcinoma and hadundergone surgery and conventional chemotherapy.† The study was supported by Wyeth-Lederle.

Perez-Gracia JL, et al. High-dose mitoxantrone and cyclophosphamide withoutstem cell support in patients with high-risk and advanced breast carcinoma: a phaseII multicentric trial. Cancer 92: 2508-2516, 15 Nov 2001 800885995

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Inpharma 12 Jan 2002 No. 13201173-8324/10/1320-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved