Final report of toxicity and efficacy of a phase II study of oral cyclophosphamide, thalidomide, and prednisone for patient

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Oncologist. 2007 Jan;12(1):99-106.

Finalr eport of toxicity and efficacy of a phase II study of oral
cyclophosphamide, thalidomide, and prednisone for patients with
relapsed or refractory multiple myeloma: A Hoosier Oncology Group
Trial, HEM01-21.

Suvannasankha A, Fausel C, Juliar BE, Yiannoutsos CT, Fisher WB, Ansari RH, Wood LL, Smith GG, Cripe LD, Abonour R.
of Hematology and Oncology, Department of Medicine, Indiana University
School of Medicine, 1044 West Walnut Street, Indianapolis, Indiana
46202, USA.
Thalidomide has direct
antimyeloma and immunomodulatory effects. In addition, both thalidomide
and metronomic chemotherapy inhibit angiogenesis. The synergy of such a
combination may decrease toxicity while maintaining efficacy.
Hoosier Oncology Group conducted a phase II trial of oral
cyclophosphamide (50 mg b.i.d. for 21 days), thalidomide (200 mg/day),
and prednisone (50 mg q.o.d.) (CTP) per 28-day course in patients with
relapsed multiple myeloma (MM). Of the 37 patients enrolled, 16 had
prior stem cell transplantation. The median follow-up time was 25.3
months (95% confidence interval [CI] 23.2-27.7).
Of 35 patients
treated, 22 patients (62.9%) responded: 7 (20.0%) complete responses, 2
(5.7%) near-complete responses, and 13 (37.1%) partial responses. Eight
patients (22.9%) had stable disease, and three (8.6%) had disease
progression. Two patients withdrew from the study early due to reasons
unrelated to progression or toxicity and were treated as nonresponders.
The median time to best response and time to progression were 3.6
months (95% CI 2.8-10.9) and 13.2 months (95% CI 9.4-21.0),
respectively. The median number of treatment cycles was seven (range
1-12 cycles). Grade III to IV toxicities included leukopenia (42.9%;
febrile neutropenia, 11.4%), hyperglycemia (20%), sensory neuropathy
(11.4%), thromboses (8%), and motor neuropathy (5.7%). No patient
withdrew from the study due to toxicity.
The efficacy and low toxicity
of the CTP regimen support the future development of such an approach
in MM.