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Autologous Bone Marrow Transplantation - Blog Science Connections

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478 Phase I and II Studies of Alkylating Agents in Breast Cancer<br />

Supportive Care<br />

Patients were housed in single rooms in reverse isolation. They received<br />

irradiated blood products (15 Gy) to maintain their platelet count at more<br />

than 20,000/mm 3<br />

and their hematocrit at more than 30%. If they became<br />

febrile, they were treated promptly with broad-spectrum antibiotics, followed<br />

by empiric i.v. amphotericin B if the fever persisted more than 48 hours.<br />

Parenteral nutrition was given when the patient's oral intake was less than 50%<br />

of the standard caloric requirement.<br />

Evaluation of Extrahematologic<br />

Toxicity<br />

Mucositis was considered as mild if the patient complained of soreness<br />

during meals, moderate if the patient was unable to eat, and severe if the pain<br />

required narcotics. Diarrhea was coded as mild for watery stools of less than<br />

500 ml/day, moderate if diarrhea was more than 500 ml with pain, and severe<br />

when associated with hemorrhage.<br />

RESULTS<br />

Antitumors! Response<br />

Two patients died during the first month after ABMT. Six patients were<br />

évaluable: four had a complete response, one a partial response, and one had<br />

stable disease. Median duration of responses was 5.5 months (range, 3-24<br />

months).<br />

Overall, of the nine patients évaluable after 1 month, six experienced<br />

disease progression, and three are in continuous complete remission with a<br />

short follow-up. Among the six patients who relapsed, two had metastatic<br />

cancers that progressed, and four patients had a thoracic recurrence, with<br />

skin and subcutaneous involvement.<br />

Hematologic Toxicity<br />

As Table 2 shows, all patients had evidence of engraftment, granulocytopenia<br />

(fewer than 500/granular leukocytes/mm 3 ) lasting a median of 14<br />

days (range, 8-37 days), and thrombocytopenia (fewer than 50,000<br />

platelets/mm 3 ) a median of 27 days (range, 20-50 days).<br />

Extrahematologic Toxicity<br />

Two patients with multiresistant metastasis died early of viral infection<br />

and heart failure. Moderate or severe mucositis occurred in 6 of the 11<br />

patients, and moderate or severe diarrhea in 4 of the 11 patients. Extrahematologic<br />

toxicity was neither more frequent nor more severe in patients receiving<br />

additional alkylating agents in addition to melphalan. One patient,<br />

conditioned with mitoxantrone, cyclophosphamide, and melphalan, developed<br />

renal failure hours after the marrow infusion; his renal function returned

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