Superior 12-yr Survival (66% vs 30%) with 5-yr Continuous (Rc) vs “Discontinuous” Remission (Rd): Results of Total Therapies 1 & 2 (TT1,2) for Multiple Myeloma (MM).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 1153-1153
Author(s):  
Bart Barlogie ◽  
Erik Rasmussen ◽  
Guido Tricot ◽  
Teresa Milner ◽  
Elias Anaissie ◽  
...  
Keyword(s):  
Overall Survival ◽  
Laboratory Data ◽  
High Dose ◽  
Key Factors ◽  
Remission Status ◽  
Bone Marrow Plasma ◽  
Study Characteristics ◽  
Pre Treatment ◽  
High Dose Melphalan

Abstract Background: The extension of overall survival (OS) in MM has been partly linked to increasing CR rates especially with high-dose melphalan. Data bases of TT1 and TT2 were examined to determine whether 5-yr Rc was key to prolonged OS. Patients and Methods: TT1 enrolled 231 and TT2 668 patients (median follow-up, 4 years). Pre-study characteristics of Rc vs Rd patients surviving >= 5yrs were compared. Furthermore, subsequent OS was examined in the context of pre-treatment variables, TT2 vs TT1 and Rc vs Rd. Only those Rd patients who were event-free (CR or PR) at least 1 year prior to the 5-yr landmark were included in this analysis. Results: Among 231 TT1 + TT2 patients surviving >= 5yrs, more TT2 patients were Rc compared to Rd (60% vs 19%, p<0.001) and more older patients were Rc (at least 65: 13% vs 3%, p=0.019). Importantly, baseline LDH, B2M, CRP, albumin, presence of cytogenetic abnormalities (CA) and whether thalidomide was part of TT2 were evenly distributed among Rc and Rd groups. Furthermore, the 5-yr risk profile of Rc patients was lower than that of Rd patients: lower bone marrow plasma cell % (at least 33%: 0% vs 14%, p=0.003), higher albumin (less than 3.5g/dL: 7% vs 16%, p=0.047), higher Hb (less than 10g/dL: 4% vs 16%, p=0.023), less frequent CA13 (1% vs 11%, p=0.007). Rc patients had significantly longer subsequent survival than those with Rd (12-year survival from enrollment and 7 yrs post-landmark: 66% vs 30%, p<0.001) (Figure). In addition to Rc, univariately significant factors for post 5-year OS were data at 5 years on CA, albumin, B2M, CRP and creatinine. Rc and no CA at 5yrs were the key factors favoring long subsequent survival; thus, 12-yr OS rates decreased from 57% in the 94 patients with Rc/noCA to 44% in 44 with noRC/noCA; 8 of 9 noRc/CA patients have died by year eight; 1 of the 8 Rc/CA patients has died. Conclusion: 5-yr Rc appears to be an important prerequisite for prolonged subsequent OS, which could be significantly increased with better therapy (TT2 vs TT1). Post-5-yr favorable survival predictors included several laboratory data at 5yrs, especially absence of CA. Overall Survival from 5 Years Post Enrollment by Remission Status at 5 Years (Interrupted vs Continuous Remisssion) Overall Survival from 5 Years Post Enrollment by Remission Status at 5 Years (Interrupted vs Continuous Remisssion)

High Dose Melphalan with Autologous Stem Cell Transplantation Overcomes Poor Prognosis of Primary Amyloidosis

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 1350-1350
Author(s):  
Simrit Parmar ◽  
Mubeen Khan ◽  
Gabriela Rondon ◽  
Nina Shah ◽  
Qaiser Bashir ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Stem Cell ◽  
Plasma Cells ◽  
High Dose ◽  
Al Amyloidosis ◽  
Hematologic Response ◽  
Bone Marrow Plasma ◽  
Organ Response ◽  
High Dose Melphalan

Abstract Abstract 1350 Background: Systemic Primary AL Amyloidosis is a rare but potentially fatal disease resulting from tissue deposits of amyloid fibrils derived from monoclonal immunoglobulin light chains. High-dose melphalan followed by autologous hematopoietic stem cell transplant (auto HCT) is associated with hematologic and organ responses and improved survival. Methods: In this retrospective analysis we identified 46 patients with primary AL amyloidosis who received auto HCT between 01/1998 to 05/2010 at MDACC. Organ responses were determined using Amyloidosis Consensus Criteria. Results: The median age at auto HSCT was 56 years (34-74) where 61% were males and 35% were older than 60 years of age. 61% had lambda light chain restriction and only 4% had cytogenetic abnormalities. Disease characteristics are summarized in Table 1. The median time from diagnosis to auto HCT was 6.6 months (2.2-29.4 months). 22 pts (47.8%) had one organ, 19 pts (41.3%) had 2 organ and 4 pts (8.7%) had 3 organ involvement. 11 pts (23.9%) had heart and 35 pts (76.1%) had kidney involvement. The median follow up from the time of diagnosis was 22.4 months and from time of auto HCT was 16.7 months. High dose Melphalan dose was 200mg/m2 in 24 pts (52%) and 140mg/m2 in 22 (47.8%). There were 4 early deaths and 4 pts whose follow up was less than 3 months and their response was not assessed. Out of the 38 evaluable patients, the post-transplant organ responses were as follows ≥PR 25(66%), ≥stable disease 35(92%) (Table2). The hematologic responses were: CR=5 (13%), ≥VGPR=10(26%), ≥PR=26 (68%), ≥SD=37(97%). One patient had progressive disease. There was a correlation between organ response and hematologic response (chi square;p<10-3). The day-100 treatment related mortality (TRM) was 8.7% and 1-yr TRM was 13%. The median progression-free (PFS) and overall survival (OS) from auto HCT was 73.8 months and not reached (from transplant). The median PFS and OS from diagnosis were 93 months and 59.8 months respectively. In multivariate analysis, heart involvement (p=0.01), female sex (p=0.011), age ≥60 years (p=0.002), bone marrow plasma cells≥10% (p=0.043) and Beta-2 microglobulin>3.5mg/l (p=0.02) were associated with poor OS. Improved OS correlated with organ response (52.6 vs 11.4 months; p=0.01) and hematologic response (52.6 vs.6.1months; p=0.002). Hemoglobin <10 g/dl (p=0.047), bone marrow plasma cells≥10% (p=0.043) and age≥60 years (p=0.075) were associated with shorter PFS. Hematologc response (p=0.48) and organ response (p=0.12) were not associated with improved PFS. Conclusion: In this analysis the outcome of patients with primary systemic AL amyloidosis was durable with auto HCT with acceptable mortality risk and improved survival. Disclosures: No relevant conflicts of interest to declare.

Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) Induction Followed By ASCT with HDM or Bor-HDM Conditioning Regimens: A Single Center Experience

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5492-5492
Author(s):  
Victor H Jimenez-Zepeda ◽  
Peter Duggan ◽  
Paola Neri ◽  
Ahsan Chaudhry ◽  
Joanne Luider ◽  
...  
Keyword(s):  
Research Funding ◽  
Clinical Characteristics ◽  
Plasma Cells ◽  
High Dose ◽  
Single Center Experience ◽  
Bone Marrow Plasma ◽  
Conventional Cytogenetics ◽  
High Dose Melphalan ◽  
The Impact

Abstract Introduction Preclinical and clinical data suggest that bortezomib in combination with high-dose melphalan (Bor-HDM) provides with a synergistic effect able to improve response for MM patients undergoing auto-SCT. In the present study, patients receiving Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) induction followed by ASCT with Bor-HDM and HDM alone were evaluated. Methods All consecutive patients treated with CyBorD induction at our center from 01/2010 to 01/2015 were evaluated. All patients received induction chemotherapy before undergoing auto-SCT. Patients received conditioning with either HDM at 200 mg/m2 (or adjusted as per renal failure) or HDM with Bortezomib (Bor-HDM). Definitions of response and progression were used according to the EBMT modified criteria. MRD negativity was assessed by flow cytometry at day-100 post-ASCT. Results Clinical characteristics are shown in Table 1. Among 66 cases receiving CyBorD induction, 42 were conditioned with Bor-HDM and 24 with HDM. At the time of analysis, 90.5% and 91.7% of patients in the Bor-HDM and HDM group are still alive and 4 and 5 patients have already progressed, respectively. At day-100 post ASCT, ORR of 97%, with CR/VGPR rate of 81% was seen in the Bor-HDM group compared to 91% and 70% in the HDM group (p=0.2). MRD negativity was higher in the Bor-HDM group (29.2%) compared to HDM (9%) (p=0.04). Median OS and PFS was similar for Bor-HDM and HDM (p=0.8) with a median follow-up of 12 months. In conclusion, CyBorD is an efficacious regimen for patients with MM and overall seemed to be well tolerated. Our data is one of the first to show the impact of this regimen on MRD negativity rates after receiving HDM or Bor-HDM conditioning, suggesting that higher rates of MRD negativity are seen with Bor-HDM. Further evaluation on a prospective manner and longer follow-up is required to assess the impact of Bor-HDM on OS and PFS. Table 1. Clinical Characteristics of patients with MM undergoing single auto-ASCT treated with CyBorD induction at our Institution Characteristic HDM (n=24) Bor-HDM (42) Age (median) 55 57 GenderMaleFemale 19 (79.1%)5 (20.9%) 25 (59.5%)17 (40.5%) Hb (g/L) 104 (75-157) 106 (76-139) Calcium (µmol/L) 2.3 (1.92-3.28) 2.3 (1.97-3.12) Creatinine (µmol/L) 86 (60-426) 84 (49-950) B2microglobulin (µmol/L) 2.73 (1.55-14.7) 3.41 (1.47-8.47) Albumin (g/L) 32 (21-43) 31 (16-42) Stage IStage IIStage III 7 (29.1%)14 (58.3%)3 (12.5%) 6 (14.2%)25 (59.5%)11 (26.1%) LDH (IU/L) 172 (71-448) 192 (103-669) BMPC (%) 32% (5-84%) 38% (5-90%) Heavy chain:IgGIgAIgDBiclonalIgMFLC oncly 17(70.8%)4 (16.6%)01 (4.1%)0 (1.5%)2 (8.3%) 22 (52.3%)10 (23.8%)01 (2.3%)1 (2.3%)8 (19%) Light chain:KappaLambdaBiclonal 17 (77.2%)5 (20.8%)1 (2%) 21 (50%)20 (47.6%)1 (2.3%) High risk (t(4;14), t(14;16), p53 del, del 13q by CCStandard risk 9 (37.5%)15 (62.5%) 11 (26.1%)31 (73.9%) BMPC: Bone marrow plasma cells; FLC: Free-light chains only; CC: Conventional cytogenetics Disclosures Jimenez-Zepeda: J&J: Honoraria; Amgen: Honoraria; Celgene: Honoraria. Duggan:Jansen: Honoraria; Celgene: Honoraria. Neri:Celgene: Research Funding. Bahlis:Johnson & Johnson: Speakers Bureau; Johnson & Johnson: Consultancy; Amgen: Consultancy; Johnson & Johnson: Research Funding; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau.

Phase I-II Trial of Tandem Autologous Transplantation with Melphalan Followed by Total Marrow Irradiation Ablative Therapy in Patients with Responding or Stable Mutiple Myeloma.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3151-3151 ◽  
Author(s):  
George Somlo ◽  
Paul Frankel ◽  
Ricardo Spielberger ◽  
Chatchada Karanes ◽  
Amrita Krishnan ◽  
...  
Keyword(s):  
Overall Survival ◽  
Autologous Transplantation ◽  
Progression Free Survival ◽  
High Dose ◽  
Ablative Therapy ◽  
Total Marrow Irradiation ◽  
Total Body ◽  
Grade 3 ◽  
High Dose Melphalan

Abstract Abstract 3151 Background: Ablative dose total body irradiation (TBI) of 800 cGy in combination with high-dose melphalan (MEL) as part of single cycle autologous transplantation (AT) was found to be too toxic, and therefore inferior, in comparison to MEL. We set out to test total marrow irradiation, (TMI), a “sculpted” form of targeted total body irradiation using image-guided intensity modulated helical tomotherapy, given as the sole ablative regimen during the second cycle of tandem AT (TAT) as consolidation in patients with stable/responsive myeloma. Patients and Methods: Patients with Durie-Salmon stages I-III multiple myeloma in response or with stable disease, who were ≤ 70 years old and within 18 months from diagnosis, were enrolled. Patients received MEL 200 mg/m2 and AT (cycle 1), and, following recovery, TMI and AT were administered (cycle 2) at a median of approximately 2 months after the first AT. During the phase I part, TMI was tested between 1000 cGy and 1800 cGy given twice daily × 5 days. The maximum tolerated dose (MTD) –as previously reported- was established at 1600 cGy [Somlo et al. Clin Cancer Res. 2011; 17 (1):174–82]. Following cycle 2 of TAT, maintenance therapy consisted of dexamethasone 40 mg/day × 4 days and an IMiD (first thalidomide, and during the phase II portion, lenalidomide) in a 28-day cycle, administered for 6 cycles for patients in complete response (CR), or for a minimum of 12 cycles for pts not in CR. Results: 54 patients were enrolled (23 females, 31 males). The median age was 54.2 years (range 31.5–66.9). All patients with stage I (7), II (14), III (n=33) multiple myeloma received MEL. Forty-three patients (79.6%) received TMI, 30 at the MTD (6 enrolled at the MTD did not receive TMI). Reversible grade 3 non-hematologic toxicities following TMI at the MTD included febrile neutropenia (5/30), electrolyte abnormalities (7/30), sepsis/infection (5/30), anorexia (2/30), nausea/vomiting (2), fatigue (1), syncope (1). Grade 3 late toxicities include 1 case each of fatigue, nausea, 1 myositis and transaminitis. There were no primary or secondary graft failures, or second malignancies. Of the entire cohort of 54 patients, by intent to treat analysis best responses following TAT included CR (n: 20), very good partial response (VGPR, n:11), partial response (PR, n:16). At a median follow-up of 39 months from first AT, progression-free survival is 55% (95% CI 42–73%) and overall survival is 81% (95% CI 70–94%). For patients treated at the MTD of TMI 1600 cGy, at a median follow-up of 39 months from the first AT, progression-free survival (PFS) is 66% (50–88%), and overall survival (OS) is 80% (65–99%). Conclusion: TMI of 1600 cGy is feasible as ablative therapy following recovery from high-dose melphalan and AT. CR and VGPR rates are expected to improve with time on maintenance therapy and such data as well as progresion-free and overall survival will be updated. Safety and progression-free and overall survival data are encouraging, and further assessment of the role of TMI is warranted in combination with MEL as part of either single AT, part of TAT, or in comparison of tandem versus single ablative therapy, both in the upfront, and salvage settings. Disclosures: Off Label Use: IMiDs as maintenance.

scholarly journals Low value of whole-body dual-modality [18f]fluorodeoxyglucose positron emission tomography/computed tomography in primary staging of stage I–II nasopharyngeal carcinoma: a nest case-control study

2021 ◽  
Author(s):  
Bei-Bei Xiao ◽  
Qiu-Yan Chen ◽  
Xue-Song Sun ◽  
Ji-Bin Li ◽  
Dong-hua Luo ◽  
...  
Keyword(s):  
Overall Survival ◽  
Lymph Node ◽  
Lymph Nodes ◽  
Stage I ◽  
Relapse Free Survival ◽  
Retropharyngeal Lymph Node ◽  
Free Survival ◽  
Pet Ct ◽  
Pre Treatment

Abstract Objectives The value of using PET/CT for staging of stage I–II NPC remains unclear. Hence, we aimed to investigate the survival benefit of PET/CT for staging of early-stage NPC before radical therapy. Methods A total of 1003 patients with pathologically confirmed NPC of stages I–II were consecutively enrolled. Among them, 218 patients underwent both PET/CT and conventional workup ([CWU], head-and-neck MRI, chest radiograph, liver ultrasound, bone scintigraphy) before treatment. The remaining 785 patients only underwent CWU. The standard of truth (SOT) for lymph node metastasis was defined by the change of size according to follow-up MRI. The diagnostic efficacies were compared in 218 patients who underwent both PET/CT and CWU. After covariate adjustment using propensity scoring, a cohort of 872 patients (218 with and 654 without pre-treatment PET/CT) was included. The primary outcome was overall survival based on intention to treat. Results Retropharyngeal lymph nodes were metastatic based on follow-up MRI in 79 cases. PET/CT was significantly less sensitive than MRI in detecting retropharyngeal lymph node lesions (72.2% [62.3–82.1] vs. 91.1% [84.8–97.4], p = 0.004). Neck lymph nodes were metastatic in 89 cases and PET/CT was more sensitive than MRI (96.6% [92.8–100.0] vs. 76.4% [67.6–85.2], p < 0.001). In the survival analyses, there was no association between pre-treatment PET/CT use and improved overall survival, progression-free survival, local relapse-free survival, regional relapse-free survival, and distant metastasis-free survival. Conclusions This study showed PET/CT is of little value for staging of stage I–II NPC patients at initial imaging. Key Points • PET/CT was more sensitive than MRI in detecting neck lymph node lesions whereas it was significantly less sensitive than MRI in detecting retropharyngeal lymph node lesions. • No association existed between pre-treatment PET/CT use and improved survival in stage I–II NPC patients.

Final overall survival in the phase 3 NETTER-1 study of lutetium-177-DOTATATE in patients with midgut neuroendocrine tumors.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4112-4112
Author(s):  
Jonathan R. Strosberg ◽  
Martyn E Caplin ◽  
Pamela L. Kunz ◽  
Philippe B Ruszniewski ◽  
Lisa Bodei ◽  
...  
Keyword(s):  
Overall Survival ◽  
Neuroendocrine Tumors ◽  
High Dose ◽  
Radioligand Therapy ◽  
Phase 3 ◽  
Long Term Follow Up ◽  
Long Acting ◽  
Safety Signals

4112 Background: As demonstrated in the primary analysis of the phase 3 NETTER-1 trial, 177Lu-DOTATATE significantly prolonged progression-free survival (PFS) versus high-dose long-acting octreotide, with a HR of 0.18 (95% CI: 0.11, 0.29; p < 0.0001), in patients with advanced, progressive, well-differentiated, somatostatin receptor-positive midgut neuroendocrine tumors (NETs). Here we report final overall survival (OS) for NETTER-1. Methods: In this international open-label trial, eligible patients were randomized to receive either four cycles of 177Lu-DOTATATE 7.4 GBq (200 mCi) every 8 ± 1 weeks plus long-acting octreotide 30 mg or high-dose long-acting octreotide 60 mg every 4 weeks (control arm), both on top of best supportive care. After disease progression on randomized treatment or completion of an 18-month treatment period, patients in both arms entered long-term follow-up and could receive further anti-cancer treatment as recommended by their physicians. The primary endpoint was PFS per RECIST 1.1 and OS was a key secondary endpoint. Primary intention-to-treat analysis of OS was prespecified to take place after 158 deaths or 5 years after the last patient was randomized, whichever occurred first. Results: Of 231 randomized patients, 101/117 (86.3%) in the 177Lu-DOTATATE arm and 99/114 (86.8%) in the control arm entered long-term follow-up. Final analysis occurred 5 years after the last patient was randomized, following 142 deaths, with a median follow-up of more than 76 months. During long-term follow-up, 41/114 (36%) of patients in the control arm received subsequent radioligand therapy (“cross-over”), the majority (22.8%) within 24 months. Median OS was 48.0 months (95% CI: 37.4, 55.2) in the 177Lu-DOTATATE arm and 36.3 months (95% CI: 25.9, 51.7) in the control arm. HR was 0.84 (95% CI: 0.60, 1.17) with p = 0.30 (unstratified 2-sided log-rank test). A total of 2/112 (1.8%) 177Lu-DOTATATE treated patients in the study developed myelodysplastic syndrome (MDS). No new cases of MDS or acute leukemia were reported in the long-term follow-up. Overall, no new safety signals emerged during long-term follow-up. Conclusions: Median OS was 48.0 months in the 177Lu-DOTATATE arm of the NETTER-1 trial and 36.3 months in the control arm. This difference was not statistically significant, potentially impacted by a high rate (36%) of cross-over of patients in the control arm to radioligand therapy after progression. In overall conclusion, the NETTER-1 study demonstrated that 177Lu-DOTATATE yielded a clinically and statistically significant improvement in PFS as a primary endpoint (HR: 0.18, p < 0.0001) as well as a clinically meaningful trend towards improvement in median OS of 11.7 months. No new safety signals emerged during the 5-year long-term follow-up. Clinical trial information: NCT01578239.

Sarcomatoid Renal Cell Carcinoma: Biologic Behavior, Prognosis, and Response to Combined Surgical Resection and Immunotherapy

1999 ◽  
Vol 17 (2) ◽  
pp. 523-523 ◽  
Author(s):  
Thomas Cangiano ◽  
Joseph Liao ◽  
John Naitoh ◽  
Frederick Dorey ◽  
Robert Figlin ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Multivariate Analysis ◽  
Cell Carcinoma ◽  
Surgical Resection ◽  
Median Duration ◽  
Renal Cell ◽  
High Dose ◽  
Risk Of Death

PURPOSE: Sarcomatoid variants of renal cell carcinoma (RCC) are aggressive tumors that respond poorly to immunotherapy. We report the outcomes of 31 patients with sarcomatoid RCC treated with a combination of surgical resection and immunotherapy. PATIENTS AND METHODS: Patients were identified from the database of the University of California Los Angeles Kidney Cancer Program. We retrospectively reviewed the cases of 31 consecutive patients in whom sarcomatoid RCC was diagnosed between 1990 and 1997. Clinical stage, sites of metastasis, pathologic stage, and type of immunotherapy were abstracted from the medical records. The primary end point analyzed was overall survival, and a multivariate analysis was performed to distinguish any factors conferring an improved survivorship. RESULTS: Twenty-six percent of patients were male and 74% were female, and the median age was 59 years (range, 34 to 73 years). Length of follow-up ranged from 2 to 77 months (mean, 21.4 months). Twenty-eight patients (84%) had known metastases at the time of radical nephrectomy (67% had lung metastases and 40% had bone, 21% had liver, 33% had lymphatic, and 15% had brain metastases). Twenty-five patients (81%) received immunotherapy, including low-dose interleukin (IL)-2–based therapy (five patients), tumor-infiltrating lymphocyte–based therapy plus IL-2 (nine patients), high-dose IL-2–based therapy (nine patients), dendritic cell vaccine–based therapy (one patient), and interferon alpha–based therapy alone (one patient). Two patients (6%) achieved complete responses (median duration, 46+ months) and five patients (15%) achieved partial responses (median duration, 36 months). One- and 2-year overall survival rates were 48% and 37%, respectively. Using a multivariate analysis, age, sex, and percentage of sarcomatoid tumor (< or > 50%) did not significantly correlate with survival. Improved survival was found in patients receiving high-dose IL-2 therapy compared with patients treated with surgery alone or any other form of immunotherapy (P = .025). Adjusting for age, sex, and percentage of sarcomatoid tumor, the relative risk of death was 10.4 times higher in patients not receiving high-dose IL-2 therapy. Final pathologic T stage did not correlate significantly with outcome, but node-positive patients had a higher death rate per year of follow-up than did the rest of the population (1.26 v 0.76, Cox regression analysis). CONCLUSION: Surgical resection and high-dose IL-2–based immunotherapy may play a role in the treatment of sarcomatoid RCCs in select patients.

Adjuvant chemotherapy for patients with high-grade soft-tissue sarcomas of the extremity.

1988 ◽  
Vol 6 (9) ◽  
pp. 1491-1500 ◽  
Author(s):  
A E Chang ◽  
T Kinsella ◽  
E Glatstein ◽  
A R Baker ◽  
W F Sindelar ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Dose Regimen ◽  
Soft Tissue Sarcomas ◽  
Disease Free Survival ◽  
High Dose ◽  
Free Survival ◽  
High Dose Regimen ◽  
Disease Free

We have previously reported the results of a randomized trial that demonstrated the survival benefit of adjuvant chemotherapy in the treatment of patients with high-grade extremity sarcomas compared with no chemotherapy. This regimen included doxorubicin, cyclophosphamide, and methotrexate. This report updates and extends our experience. The median follow-up of this trial is now 7.1 years and reveals a 5-year disease-free survival of 75% and 54% for chemotherapy and no chemotherapy groups, respectively (two-sided P [P2] = .037). The 5-year overall survival for patients in this trial was 83% and 60% for the chemotherapy and no chemotherapy groups, respectively, with a trend towards improved survival in the chemotherapy arm (P2 = .124). Because of doxorubicin-induced cardiomyopathy we performed a subsequent randomized trial comparing this high-dose regimen to reduced cumulative doses of doxorubicin and cyclophosphamide without methotrexate. Eighty-eight patients were entered into this trial which has a median follow-up of 4.4 years. The 5-year disease-free and overall survival for patients treated with the reduced doses of chemotherapy was 72% and 75%, respectively, and was not significantly different from the high-dose regimen. No patients developed congestive heart failure on this study. We conclude that adjuvant chemotherapy improves disease-free survival in patients with extremity soft-tissue sarcomas. The overall survival advantage in patients receiving adjuvant chemotherapy in our initial randomized high-dose chemotherapy trial has diminished though it continues to favor the chemotherapy group. A reduced-dose chemotherapy regimen was found to be comparable to the high-dose regimen.

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