The purpose of this study was to determine the effectiveness of second mobilization strategies in patients who yielded < 2.5 x 10(6) CD34+ PBSC/kg after initial mobilization. Repeat mobilization attempts were made with chemotherapy and G-CSF (n = 61) or G-CSF alone (n = 58) in patients who failed initial mobilization with chemotherapy and G-CSF (n = 92) or G-CSF alone (n = 27). A median of 0.27 x 10(6) CD34+ cells/kg per apheresis was collected after the second mobilization, compared with 0.16 with initial harvests (p = 0.0001). Forty-eight percent achieved a target CD34+ cell dose > or = 2.5 x 10(6)/kg when harvests from the first and second mobilizations were combined. Fifteen of 17 patients (88%) with > or = 1.5 x 10(6) CD34+ cells/kg harvested after first mobilization had > or = 2.5 x 10(6) CD34+ cells/kg collected when first and second harvests were combined, as compared with 42 of 102 (41%) achieving < 1.5 x 10(6) CD34+ cells/kg with first PBSC harvests (p = 0.0001). Second mobilizations with chemotherapy and G-CSF or G-CSF alone resulted in similar CD34+ cell yields. Toxicities of second mobilizations were comparable with those of first mobilizations. Seventy-nine patients (66%) received high-dose chemotherapy with PBSC support, with recovery of neutrophils and platelets in a median of 11 and 15 days, respectively. Transplant-related mortality was 4%, and event-free survival at 2 years was 0.34. It was concluded that second mobilization attempts in patients who fail to achieve > or = 2.5 x 10(6) CD34+ cells/kg on initial mobilization were successful in 48% of patients. G-CSF alone was as effective as chemotherapy plus G-CSF in mobilizing CD34+ cells and was associated with less morbidity.

Summary:This study was designed to determine the maximum tolerated dose (MTD) of high-dose melphalan (HDM), with peripheral blood stem cell support, that could be given twice within 90 days to patients with multiple myeloma. Twenty patients received tandem HDM at 160, 180 or 200 mg/m 2 and a total of 55 were treated at the estimated MTD of 200 mg/m 2 . Seventeen of 55 (31%) did not receive cycle 2; six because of low CD34 + cell yields, three because of severe (n = 1) or fatal toxicities (n = 2) and eight for other reasons. The median interval between doses for 38 patients was 70 days (range 41-225). Three of 55 patients (5%) died of treatmentrelated causes. In patients completing two cycles of HDM, at any dose level, the complete remission rate improved from 15% following cycle 1 to 55% following cycle 2. The probabilities of survival, event-free survival and relapse or progression at 18 months for the 55 patients treated at the MTD were 0.84, 0.76 and 0.20, respectively, with a median follow-up of 19 months (range 9-36) from mobilization chemotherapy. It was concluded that two cycles of HDM, 200 mg/m 2 , could be administered to approximately 70% of patients under the age of 66 with multiple myeloma in a median interval of 70 days, with improvement in CR rates. Keywords: melphalan; myeloma The Intergroupe Français du Myelome (IFM) demonstrated superiority in response, overall survival (OS) and eventfree survival (EFS) following high-dose chemotherapy (HDC) and total body irradiation (TBI) with bone marrow (BM) support for patients with newly diagnosed multiple myeloma under the age of 65, compared to conventionaldose chemotherapy. 1 Complete remissions (CR) were achieved in 5% of conventionally treated patients and 22% of patients receiving autologous BM transplants. 1 A recent 6 year follow-up shows a 21% survival for the conventional group compared to 43% for the transplant group (P = 0.03). Although cures following autologous stem transplantation have not been documented it is clear that this strategy improves the CR rate and prolongs survival. 1,2 Since it is unlikely that patients who do not achieve CR will have prolonged EFS 3-11 attempts to improve CR rates with HDC are reasonable. In order to improve CR rates in patients with multiple myeloma tandem high-dose regimens have been explored. 12 When considering tandem or sequential high-dose treatments it is generally thought to be important to deliver such therapy within a short period of time. 13 Previous studies have demonstrated the feasibility of administering two cycles of HDM at 200 mg/m 2 but the minimum time interval between doses supported by PBSC has not been established. 12 The purpose of the current study was to determine the maximum tolerated doses (MTD) of HDM supported by peripheral blood stem cells (PBSC) that could be given within 90 days and to evaluate the effect of this strategy on response rates, especially in patients who had only received initial induction chemotherapy. March 1994 and 15 September 1995, 78 patients with multiple my...

Summary:The purpose of this study was to determine outcomes for 56 patients with inflammatory breast cancer (IBC) receiving high-dose chemotherapy (HDC) with cyclophosphamide, thiotepa and carboplatin (CTCb) with peripheral blood stem cell (PBSC) support. All patients received the same total amount of chemotherapy but there were differences in the sequence of therapy: 15 received induction chemotherapy, chemotherapy mobilization of PBSC and CTCb after surgery (adjuvant group) while 41 received induction chemotherapy with (n = 17) or without (n = 24) chemotherapy for mobilization of PBSC prior to surgery and CTCb after surgery (neoadjuvant group). Median time from diagnosis to HDC was 5.5 months (range 3.5-12.5). Fifty-one patients (91%) required admission to the hospital following HDC for a median of 11 days (range 5-25). There were two (4%) infectious deaths after HDC. Twenty-four patients (43%) have relapsed at a median of 18 months (range 8-50) from diagnosis resulting in death in 34%. The probabilities of overall (OS) and event-free survival (EFS) at 3 years for all 56 patients were 0.72 and 0.53, respectively, with a median followup of 44 months (range 15-76) from diagnosis. There were no differences in OS, EFS or patterns of relapse between patients in the adjuvant or neoadjuvant groups. These sequences of combined modality therapy incorporating HDC are comparable or superior to other intensive approaches for the treatment of IBC. Further improvements will be necessary to decrease systemic recurrences. Keywords: high-dose therapy; inflammatory breast cancer Multi-modality therapy is now the standard of care for patients with inflammatory breast cancer (IBC). 1,2 The usual sequence of treatment involves induction chemotherapy followed by surgery, radiation therapy, further chemotherapy and hormonal therapy resulting in 5 year event-free survivals (EFS) of approximately 30%. 1,[3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18] The use of induction chemotherapy and local-regional radioCorrespondence: Dr CD Buckner, Response Oncology, Inc., 600 Broadway, Suite 112, Seattle, WA 98122, USA Received 18 January 1999; accepted 15 April 1999 therapy has decreased local progression of disease but the majority of patients relapse at distant sites making eradication of microscopic metastatic disease the major challenge.The potential value of high-dose chemotherapy (HDC) with hematopoietic stem cell support in patients with operable high-risk stage II-III non-inflammatory breast cancer has been reported. [19][20][21][22][23][24][25][26] Evaluation of HDC with stem cell support in patients with IBC is a logical extension of these studies.Results of autologous bone marrow (BM) transplantation for patients with IBC have been included in summaries of transplant results 27,28 and reported by the International Bone Marrow Transplant Registry. 23,29 Recently, there have been two single-center reports of outcomes for patients with stage IIIB IBC with HDC with BM or peripheral blood stem cell (PBSC) support. 30,31 These s...

We have recently completed a double-blind, placebo-controlled, noncrossover study, the goal of which was to determine whether cetiedil citrate (cetiedil) could affect the course of vaso-occlusive crises in sickle cell disease. Patients, who presented to the emergency room at least 4 but no more than 24 hours after the onset of a painful vasoocclusive crisis severe enough to require hospitalization, were considered candidates for the study. Each patient received either placebo or cetiedil at one of the following three dosages: 0.2, 0.3, or 0.4 mg/kg body weight. The assigned drug dosage was given as a 30 minute intravenous infusion every 8 hours for 4 consecutive days. A total of 67 patients was enrolled in the study. Cetiedil, at its highest dosage (0.4 mg/kg body weight), was found to be significantly superior to placebo both in reducing the number of painful sites present on all 4 treatment days and in shortening the total time in crisis. No serious adverse reactions were observed during the course of the study. We conclude that cetiedil, given at a dosage of 0.4 mg/kg body weight, is therapeutically advantageous for sickle cell crisis.

Levels of copper, haptoglobin, fibrinogen and Factor VIII were measured in 30 patients with non‐Hodgkin's lymphoma on 90 occasions in an attempt to demonstrate a possible correlation between hypercupremia and other acute phase reactants. The four parameters were measured simultaneously in active disease and in remission. The serum copper, along with other parameters, was significantly elevated in the active disease (P < 0.001) and there was a high correlation between the levels of serum copper, fibrinogen and haptoglobin (P < 0.001).