Standard chemotherapy compared with high-dose chemoradiotherapy for multiple myeloma: final results of phase III US Intergroup Trial S9321.

PURPOSE: Results of a prospective randomized trial conducted by the Intergroupe Francais du Myélome (IFM 90) indicated that autologous hematopoietic cell-supported high-dose therapy (HDT) effected higher complete response rates and extended progression-free survival (PFS) and overall survival (OS) compared with standard-dose therapies (SDT) for patients with multiple myeloma (MM). PATIENTS AND METHODS: In 1993, three North American cooperative groups launched a prospective randomized trial (S9321) comparing HDT (melphalan [MEL] 140 mg/m2 plus total-body irradiation 12 Gy) with SDT using the vincristine, carmustine, MEL, cyclophosphamide, and prednisone regimen. Responders on both arms (> or = 75%) were randomly assigned to interferon (IFN) or no maintenance treatment. RESULTS: With a median follow-up time of 76 months, no differences were observed in response rates between the two study arms (HDT, n = 261 patients; SDT, n = 255 patients). Similarly, PFS and OS durations did not differ between the HDT and SDT arms, with 7-year estimates of PFS of 17% and 16%, respectively, and OS of 37% and 42%, respectively. Of 242 patients achieving at least 75% tumor reduction, no difference was observed in PFS or OS among the 121 patients randomly assigned to IFN and the 121 patients randomly assigned to no maintenance therapy. Among 157 patients relapsing on SDT, 87 received a salvage autotransplantation; their median survival time of 30 months was only slightly better than the survival time of the remaining patients who were managed with further SDT (23 months; P = .13). CONCLUSION: The HDT and SDT regimens used in S9321 yielded comparable response rates and PFS and OS durations. IFN maintenance therapy did not benefit patients who achieved > or = 75% tumor reduction on either arm.

Use of a supportive care team for screening and preemptive intervention among multiple myeloma patients receiving stem cell transplantation.

Although peripheral blood stem-cell transplantation (PBSCT) has assumed a growing role in the treatment of multiple myeloma, very few studies have examined the functional and quality-of-life changes experienced by myeloma patients in the transplant setting. Multiple myeloma is characterized by a range of debilitating physical and psychosocial symptoms. However, supportive care needs for patients with this disease are often overlooked or managed only episodically. The current study pilot-tested an interdisciplinary supportive care program designed to provide screening and identify patients at risk early in the course of care. Participants in this pilot project were 61 patients with hematological disorders, predominantly multiple myeloma (85.3%), evaluated during their initial workup. Mean time since diagnosis was 7.4 months. Participants were interviewed by an advanced-practice nurse and completed standardized measures of heath-related quality of life (SF-12), fatigue (POMS-Fatigue), nutritional risk (PG-SGA), pain (Brief Pain Inventory), emotional functioning (Hospital Anxiety and Depression Scale), and sexual concerns (FACIT). Results indicated that difficulties were prevalent across multiple functional domains; 61.4% of patients displayed significant nutritional deficits. Physical functioning was below age-adjusted national norms for 53.5%. Moderate-to-severe fatigue was reported by 39.0%, and one third experienced clinically significant levels of pain, impaired daily functioning associated with pain, and emotional distress. A similar proportion of respondents (33.9%) reported disrupted sexual functioning and difficulty with body image. Findings suggest that early, systematic screening is feasible in a busy transplant center. The prevalence of symptoms highlights the importance of providing screening and proactive intervention for multiple myeloma patients early in the course of treatment and even prior to beginning protocols for high-dose therapy and transplantation.