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Outcomes and costs of autologous stem cell mobilization with chemotherapy plus G-CSF vs G-CSF alone.

ABSTRACT: Chemotherapy plus G-CSF (C+G) and G-CSF alone are two of the most common methods used to mobilize CD34(+) cells for autologous hematopoietic SCT (AHSCT). In order to compare and determine the real-world outcomes and costs of these strategies, we performed a retrospective study of 226 consecutive patients at 11 medical centers (64 lymphoma, 162 multiple myeloma), of whom 55% of lymphoma patients and 66% of myeloma patients received C+G. Patients with C+G yielded more CD34(+) cells/day than those with G-CSF alone (lymphoma: average 5.51 × 10(6)?cells/kg on day 1 vs 2.92 × 10(6)?cells/kg, P=0.0231; myeloma: 4.16 × 10(6) vs 3.69 × 10(6)?cells/kg, P<0.00001) and required fewer days of apheresis (lymphoma: average 2.11 vs 2.96 days, P=0.012; myeloma: 2.02 vs 2.83 days, P=0.0015), although nearly all patients ultimately reached the goal of 2 × 10(6)?cells/kg. With the exception of higher rates of febrile neutropenia in myeloma patients with C+G (17% vs 2%, P<0.05), toxicities and other outcomes were similar. Mobilization with C+G cost significantly more (lymphoma: median $10,300 vs $7300, P<0.0001; myeloma: $8800 vs $5600, P<0.0001), although re-mobilization adds $6700 for drugs alone. Our results suggest that although both C+G and G-CSF alone are effective mobilization strategies, C+G may be more cost-effective for patients at high risk of insufficient mobilization.

SUBMITTER: Sung AD

PROVIDER: S-EPMC3797171 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Outcomes and costs of autologous stem cell mobilization with chemotherapy plus G-CSF vs G-CSF alone.

Sung A D AD Grima D T DT Bernard L M LM Brown S S Carrum G G Holmberg L L Horwitz M E ME Liesveld J L JL Kanda J J McClune B B Shaughnessy P P Tricot G J GJ Chao N J NJ

Bone marrow transplantation 20130610 11

Chemotherapy plus G-CSF (C+G) and G-CSF alone are two of the most common methods used to mobilize CD34(+) cells for autologous hematopoietic SCT (AHSCT). In order to compare and determine the real-world outcomes and costs of these strategies, we performed a retrospective study of 226 consecutive patients at 11 medical centers (64 lymphoma, 162 multiple myeloma), of whom 55% of lymphoma patients and 66% of myeloma patients received C+G. Patients with C+G yielded more CD34(+) cells/day than those ...[more]

PMID: 23749109

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Project description:OBJECTIVE:Granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony stimulating factor (GM-CSF) are the two most commonly used cytokines for mobilization of stem cells in patients undergoing high dose chemotherapy with stem cell support. Both cytokines increase the peripheral blood white blood cell count and the stem cell count but there are other differences in the stem cell products mobilized by G-CSF versus those mobilized with GM-CSF. Generally higher numbers of dendritic cells are mobilized with GM-CSF than by G-CSF. The primary objective of this randomized study was to evaluate the safety and efficacy of chemotherapy plus G-CSF versus chemotherapy plus G-CSF and GM-CSF in patients with B-cell non-Hodgkin's lymphoma (NHL) who were undergoing chemo-mobilization. Secondary objectives were to determine the expression of various dendritic cell subsets in the two groups and to determine the incidence of disease progression or relapse at 12 months. METHODS:We prospectively evaluated 84 patients with relapsed NHL who were candidates for high dose therapy (HDT). All patients underwent chemo-mobilization using ifosfamide, etoposide, and rituximab. All patients were randomized in an adaptive manner to receive either G-CSF or G-CSF plus GM-CSF (G+GM) starting 24 hours after completion of chemotherapy and continuing until completion of apheresis. The stem cell yield/kg, the number of apheresis procedures needed in the two groups, and the toxicity were recorded. We also enumerated dendritic cell subsets, myeloid DCs (mDC) and plasmacytoid DCs (pDC), in apheresis products and in peripheral blood (PB) samples collected pre-chemotherapy. The data were expressed as a percentage of peripheral blood mononuclear cells. RESULTS:A total of 84 patients were treated. Forty-three patients received G-CSF and 41 received G+GM. Both regimens were well tolerated. The median CD34+ cell dose collected was similar in the two groups. A total of 54 (G-CSF N = 25 and G+GM N = 29) paired samples from baseline and post-apheresis were available for analysis of dendritic cell subsets. There was no significant difference in the percentages of mDC subsets between baseline and post-apheresis collected with G-CSF or G+GM mobilization. However, there was a significant increase in the percentage of pDC subsets in the G-CSF alone when compared to the G+GM arm (P = 0.002). Furthermore, the ratio of mDC and pDC was significantly lower after mobilization with G-CSF versus G+GM (P = 0.029). CONCLUSION:Addition of GM-CSF to G-CSF to the mobilization regimen resulted in lower percentages of pDC in the apheresis products when compared to those with G-CSF alone. This shifts the mDC/pDC ratio in the apheresis grafts in favor of mDC in the combination arm. However, these differences did not seem to impact the clinical outcomes in the two groups. (ClinicalTrials.gov Identifier: NCT00499343).

Project description:The current study aimed to evaluate the efficacy and safety of neoadjuvant apatinib plus tegafur/gimeracil/oteracil potassium (S-1) plus oxaliplatin (SOX) chemotherapy in patients with locally advanced gastric carcinoma (LAGC). Therefore, patients with LAGC treated with neoadjuvant apatinib plus SOX chemotherapy (apatinib + SOX group; n=25) or SOX chemotherapy (SOX group; n=35) were enrolled in the present study. Subsequently, the objective response (ORR) and disease control rates (DCR), pathological response, disease-free survival (DFS), overall survival (OS) and adverse events were recorded. The results showed that patients in the apatinib + SOX group exhibited a higher ORR (64.0 vs. 37.1%; P=0.040), but a similar DCR (96.0 vs. 88.6%; P=0.580), compared with those in the SOX group. The pathological response rates in patients with grade 0, 1, 2 and 3 LAGC were 0.0, 20.8, 62.5 and 16.7%, respectively, in the apatinib + SOX group, while in those treated with SOX alone they were 9.1, 39.4, 42.4 and 9.1%, respectively. By contrast, the pathological response was elevated in the apatinib + SOX group compared with the SOX group (P=0.030). During a median follow-up period of 21.0 months (range, 6.4-38.1 months), median DFS and OS were not reached. More specifically, the 1-, 2- and 3-year DFS rates were 91.7, 75.2 and 75.2% in the apatinib + SOX group and 71.8, 59.6 and 44.7% in the SOX group, respectively. In addition, the 1-, 2- and 3-year OS rates were 100.0, 89.6 and 78.4% in the apatinib + SOX group, while those in the SOX group were 90.3, 69.2 and 55.4%, respectively. However, no differences in DFS (P=0.094) or OS (P=0.155) were observed between the two groups. Additionally, the most common adverse events in the SOX group were mild leukopenia (42.9%) and fatigue (34.3%), while those in the apatinib + SOX group were tolerable leukopenia (44.0%) and hypertension (44.0%). In conclusion, the present study suggested that neoadjuvant apatinib plus SOX chemotherapy could be more effective and tolerable compared with SOX chemotherapy alone in patients with LAGC.

Project description:ImportanceDisulfiram has demonstrated broad antitumoral effect in several preclinical studies. One of the proposed indications is for the treatment of glioblastoma.ObjectiveTo evaluate the efficacy and safety of disulfiram and copper as add-on to alkylating chemotherapy in patients with recurrent glioblastoma.Design, setting, and participantsThis was a multicenter, open-label, randomized phase II/III clinical trial with parallel group design. Patients were recruited at 7 study sites in Sweden and 2 sites in Norway between January 2017 and November 2020. Eligible patients were 18 years or older, had a first recurrence of glioblastoma, and indication for treatment with alkylating chemotherapy. Patients were followed up until death or a maximum of 24 months. The date of final follow-up was January 15, 2021. Data analysis was performed from February to September 2022.InterventionsPatients were randomized 1:1 to receive either standard-of-care (SOC) alkylating chemotherapy alone, or SOC with the addition of disulfiram (400 mg daily) and copper (2.5 mg daily).Main outcomes and measuresThe primary end point was survival at 6 months. Secondary end points included overall survival, progression-free survival, adverse events, and patient-reported quality of life.ResultsAmong the 88 patients randomized to either SOC (n = 45) or SOC plus disulfiram and copper (n = 43), 63 (72%) were male; the mean (SD) age was 55.4 (11.5) years. There was no significant difference between the study groups (SOC vs SOC plus disulfiram and copper) in 6 months survival (62% [26 of 42] vs 44% [19 of 43]; P = .10). Median overall survival was 8.2 months (95% CI, 5.4-10.2 months) with SOC and 5.5 months (95% CI, 3.9-9.3 months) with SOC plus disulfiram and copper, and median progression-free survival was 2.6 months (95% CI, 2.4-4.6 months) vs 2.3 months (95% CI, 1.7-2.6 months), respectively. More patients in the SOC plus disulfiram and copper group had adverse events grade 3 or higher (34% [14 of 41] vs 11% [5 of 44]; P = .02) and serious adverse events (41% [17 of 41] vs 16% [7 of 44]; P = .02), and 10 patients (24%) discontinued disulfiram treatment because of adverse effects.Conclusions and relevanceThis randomized clinical trial found that among patients with recurrent glioblastoma, the addition of disulfiram and copper to chemotherapy, compared with chemotherapy alone, resulted in significantly increased toxic effects, but no significant difference in survival. These findings suggest that disulfiram and copper is without benefit in patients with recurrent glioblastoma.Trial registrationClinicalTrials.gov Identifier: NCT02678975; EUDRACT Identifier: 2016-000167-16.

Project description:Importance:Locoregional failure for patients with locally advanced bladder cancer (LABC) after radical cystectomy (RC) is common even with chemotherapy and is associated with high morbidity and mortality. Adjuvant radiotherapy (RT) can decrease locoregional failure but has not been studied in the chemotherapy era. Objective:To investigate if adjuvant sequential RT plus chemotherapy can improve locoregional recurrence-free survival (LRFS) compared with adjuvant chemotherapy alone. Design, Setting, and Participants:A randomized phase 3 trial was opened to compare adjuvant RT vs sequential chemotherapy plus RT after RC for LABC, but a third arm was added later as a randomized phase 2 trial to compare chemotherapy plus RT vs adjuvant chemotherapy alone, an emerging standard. The intent-to-treat phase 2 trial reported herein enrolled patients from December 2002 to July 2008. Data were analyzed from August 3, 2015, to January 6, 2016. Routine follow-up and surveillance pelvic computed tomographic (CT) scans every 6 months during the first 2 years were performed. The setting was an academic center. Patients with bladder cancer 70 years or younger having 1 or more risk factors (≥pT3b, grade 3, or positive nodes) with negative margins after radical cystectomy plus pelvic lymph node dissection were eligible. Patients had Eastern Cooperative Oncology Group performance status of 0 to 2, no evidence of distant metastases on CT scan of the abdomen and pelvis or on chest imaging, and adequate renal, hepatic, and hematologic function. Ninety-one percent (109 of 120) had ≥ pT3 disease. Interventions:Chemotherapy plus RT included 2 cycles of gemcitabine (1000 mg/m2 intravenously on days 1, 8, and 15) and cisplatin (70 mg/m2 intravenously on day 2) before and after RT to 4500 cGy in 150 cGy twice-daily fractions over 3 weeks using 3-dimensional conformal techniques. Chemotherapy alone included 4 cycles of gemcitabine and cisplatin. Main Outcome and Measure:Locoregional recurrence-free survival. Results:The chemotherapy plus RT arm accrued 75 patients, and the chemotherapy-alone arm accrued 45 patients, with a weighted randomization to speed accrual. Fifty-three percent (64 of 120) had urothelial carcinoma, and 46.7% (56 of 120) had squamous cell carcinoma or other. The arms were balanced except for age (median, 52 vs 55 years; P = .04) and tumor size (mean, 4.9 vs 5.8 cm; P < .01), both favoring chemotherapy plus RT. Two-year outcomes and overall adjusted hazard ratios (HRs) for chemotherapy plus RT vs chemotherapy alone were 96% vs 69% (HR, 0.08; 95% CI, 0.02-0.39; P < .01) for LRFS, 68% vs 56% (HR, 0.53; 95% CI, 0.27-1.06; P = .07) for disease-free survival, and 71% vs 60% (HR, 0.61; 95% CI, 0.33-1.11; P = .11) for overall survival (OS). Five patients (7%) had RT-associated late grade 3 gastrointestinal tract adverse effects in the chemotherapy plus RT arm. Conclusions and Relevance:Adjuvant chemotherapy plus RT was reasonably well tolerated and was associated with significant improvements in LRFS and marginal improvements in disease-free survival vs chemotherapy alone in LABC. The addition of adjuvant RT should be considered for LABC. This regimen warrants further study in phase 3 trials. Trial Registration:clinicaltrials.gov Identifier: NCT01734798.

Project description:BackgroundRituximab has been shown to improve response rates and progression free survival when added to chemotherapy in patients with indolent and mantle cell lymphoma. However, the impact of R on overall survival (OS) when given in combination with chemotherapy (R-chemo) has remained unclear so far.ObjectivesWe thus performed a comprehensive systematic review in this group of patients to compare R-chemo with chemotherapy alone with respect to OS. Other endpoints were overall response rate (ORR), toxicity and disease control as assessed by measures such as time to treatment failure (TTF), event free-survival (EFS), progression free-survival (PFS) and time to progression (TTP).Search strategyWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE and conference proceeding from 1990 to 2005.Selection criteriaOnly randomised controlled trials (RCT) comparing R-chemo with chemotherapy alone in patients with newly diagnosed or relapsed indolent lymphoma and mantle cell lymphoma (MCL) were included.Data collection and analysisTwo review authors extracted data and assessed the study quality. Number needed to treat (NNT) were calculated to facilitate interpretation.Main resultsSeven randomised controlled trials involving 1943 patients with follicular lymphoma, mantle cell lymphoma, or other indolent lymphomas were included in the meta-analysis. Five studies were published as full-text articles, and two were in abstract form. Patients treated with R-chemo had better overall survival (hazard ratio [HR] for mortality 0.65; 95% confidence interval (CI) 0.54 to 0.78), overall response (relative risk of tumour response 1.21; 95% CI 1.16 to 1.27), and disease control (HR of disease event 0.62; 95% CI 0.55 to 0.71) than patients treated with chemotherapy alone. R-chemo improved overall survival in patients with follicular lymphoma (HR for mortality 0.63; 95% CI 0.51 to 0.79) and in patients with mantle cell lymphoma (HR for mortality 0.60; 95% CI 0.37 to 0.98). However, in the latter case, there was heterogeneity among the trials (P 0.07), making the survival benefit less reliable.Authors' conclusionsThe systematic review demonstrated improved OS for patients with indolent lymphoma, particularly in the subgroups of follicular and in mantle cell lymphoma when treated with R-chemo compared to chemotherapy alone.

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Outcomes and costs of autologous stem cell mobilization with chemotherapy plus G-CSF vs G-CSF alone.

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Outcomes and costs of autologous stem cell mobilization with chemotherapy plus G-CSF vs G-CSF alone.

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