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VI Autologous Bone Marrow Transplantation.pdf - Blog Science ...

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throughout their hospital stay and therapeutic antibiotic therapy as necessary.<br />

Patients were discharged from the hospital when their absolute granulocyte<br />

count was more than 500/ml for 2 consecutive days. Growth factor support was<br />

not utilized in the first few patients, but when subsequently available, recombinant<br />

human granulocyte colony stimulating factor (G-CSF) was routinely dispensed<br />

either as an i.v. infusion over 4-6 h or as a subcutaneous injection once<br />

daily in a dose of 5-10mg/kg body weight.<br />

Response Criteria<br />

Patients were seen and reevaluated at least monthly for 3 months after BMT.<br />

A complete clinical and radiological restaging was performed immediately<br />

upon hematologic reconstitution and again at 3 months after transplant and<br />

then every 3 months for 1 year; this was repeated every 4 months during year 2<br />

and then every 6 months or as clinically indicated during years 3 and 4. In patients<br />

who remained progression-free, subsequent restaging procedures were<br />

performed annually. CR was defined as disappearance of all clinical and radiological<br />

evidence of disease for a minimum of 8 weeks. PR was defined as a 50%<br />

or more decrease in the sum of the products of the diameters of all measurable<br />

lesions persisting for at least 8 weeks. Anything less was considered a treatment<br />

failure. Early death was defined as death within the first 30 days after transplant<br />

and precluded assessment of disease response.<br />

RESULTS<br />

Thirteen of the 38 treated patients achieved a CR remission and 5 patients<br />

had a PR for an overall response rate of 47% (Table 2). Four of the 17 patients<br />

who had induction-therapy-resistant disease obtained a CR with MVT and 3<br />

additional patients in this group realized a PR. With a minimum follow-up of 6<br />

months, the median time to progression for the 18 responding patients was 14<br />

months (Fig. 1). Six patients remained in CR at 8+, 15+, 18+, 21+, 46+, and 46+<br />

months. Three of the 5 patients who remained in CR after 12 months were initial<br />

induction failures. The median survival for all patients receiving MVT was 16<br />

months (Fig. 2).<br />

Seventeen patients failed to respond to MVT and 3 patients who died from<br />

treatment-related complications were regarded as inevaluable. One patient died<br />

of respiratory failure 37 days after the transplant. She had no evidence of<br />

Hodgkin's disease at autopsy. This patient had received CBV with ABMT less<br />

than 15 months prior to MVT and had also completed a course of palliative radiation<br />

therapy to the chest (total dose 46 Gy) less than 6 months prior to receiving<br />

the MVT regimen. One patient died in CR at 10 months after the transplant<br />

from complications of a (possibly secondary) myelodysplastic syndrome. Three<br />

patients died within the first 30 days of the transplant of alpha-streptococcal septicemia<br />

(day 7), pulmonary hemorrhage (day 17) and aspergillus pneumonia<br />

(day 27). These 3 early deaths and the patient who died on day 37 from progressive<br />

pulmonary failure were considered therapy-related. Thus, the risk of treatment-related<br />

mortality is about 10% with the MVT regimen.<br />

Severe mucositis, necessitating continuous i.v. opiate analgesia and parenteral<br />

nutrition for 7-14 days, was the dose-limiting toxicity and it occurred in<br />

106 SIXTH INTERNATIONAL SYMPOSIUM ON AUTOLOGOUS BONE MARROW TRANSPLANTATION

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