scholarly journals Doxorubicin/Adriamycin Monotherapy or Plus Ifosfamide in First-Line Treatment for Advanced Soft Tissue Sarcoma: A Pooled Analysis of Randomized Trials

2021 ◽  
Vol 11 ◽  
Author(s):  
Bi-Cheng Wang ◽  
Bo-Hua Kuang ◽  
Bo-Ya Xiao ◽  
Guo-He Lin
Keyword(s):  
Clinical Trials ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Randomized Clinical Trials ◽  
Objective Response ◽  
Pooled Analysis ◽  
Cochrane Library ◽  
First Line ◽  
Open Label ◽  
Advanced Soft Tissue Sarcoma

BackgroundDoxorubicin/Adriamycin (ADM) alone or combined with ifosfamide (IFO) (AI) is available for previously untreated advanced soft tissue sarcoma (ASTS). However, the clinical choice between them remains controversial. In this pooled analysis, we comprehensively compared the efficacy and tolerability of AI versus ADM in patients with ASTS.MethodsPubMed, Web of Science, EMBASE, and Cochrane Library were systematically searched from inception to April 14, 2021. Eligible studies were randomized clinical trials comparing AI to ADM. The primary outcomes were overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). Discontinuation rate (DR) and toxic death (TD) were explored as secondary outcomes.ResultsOverall, three open-label randomized phase 2/3 clinical trials with a total of 1108 newly diagnosed ASTS patients were enrolled. Between AI and ADM, pooled hazard ratios were 0.93 (95% confidence interval 0.58-1.50, p = 0.78) for OS and 0.85 (0.57-1.25, p = 0.41) for PFS. While pooled risk ratios for ORR, DR, and TD were 1.37 (0.94-1.99, p = 0.10), 1.04 (0.74-1.46, p = 0.82), and 0.68 (0.19-2.36, p = 0.54) respectively. No publication bias was observed across the studies.ConclusionIn the first-line setting, adding IFO to ADM failed to benefit ASTS patients against ADM alone, even with comparable tolerability.

Which goals should we pursue in each line of treatment for advanced soft tissue sarcoma?

2019 ◽  
Vol 15 (26s) ◽  
pp. 17-23
Author(s):  
Javier Martin-Broto ◽  
Nadia Hindi ◽  
David S Moura
Keyword(s):  
Clinical Trials ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Disease Stage ◽  
Treatment Goals ◽  
Tumor Shrinkage ◽  
First Line ◽  
Advanced Soft Tissue Sarcoma ◽  
First Line Therapy ◽  
Line Therapy

Treatment goals for advanced soft tissue sarcoma (STS) vary according to disease stage and treatment line. In potentially resectable advanced disease, the goal of treatment is tumor shrinkage to facilitate surgical resection with better margins. Doxorubicin in combination with ifosfamide (or dacarbazine) is first-line therapy of choice in this setting. Tumor shrinkage is relevant not only for surgical rescue but also to obtain rapid symptomatic relief related to tumor volume. Doxorubicin monotherapy can be selected as first-line therapy in cases where disease control with less morbidity is the objective. Second-line therapy for metastatic disease generally aims for disease stabilization with good quality of life although, in some palliative or potentially resectable cases, tumor shrinkage may be relevant. To date, treatment aim has not been a critical factor in the design of clinical trials in advanced STS. In clinical practice, however, treatment is selected according to aim. Future clinical trials in patients with advanced STS should take treatment goals into account. Using illustrative case studies, evidence is examined which supports the current approach to treatment of advanced STS.

scholarly journals Gemcitabine-Containing Chemotherapy for the Treatment of Metastatic Myxofibrosarcoma Refractory to Doxorubicin: A Case Series

2021 ◽  
Vol 28 (1) ◽  
pp. 813-817
Author(s):  
Arielle Elkrief ◽  
Suzanne Kazandjian ◽  
Thierry Alcindor
Keyword(s):  
Overall Survival ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Objective Response ◽  
Case Series ◽  
Progression Free Survival ◽  
Distant Metastases ◽  
First Line ◽  
Pleomorphic Sarcoma ◽  
Line Setting

Background: Myxofibrosarcoma is a type of soft-tissue sarcoma that is associated with high rates of local recurrence and distant metastases. The first-line treatment for metastatic soft-tissue sarcoma has conventionally been doxorubicin-based. Recent evidence suggests that myxofibrosarcoma may be molecularly similar to undifferentiated pleomorphic sarcoma (UPS), which is particularly sensitive to gemcitabine-based therapy. The goal of this study was to evaluate the activity of gemcitabine-containing regimens for the treatment of metastatic myxofibrosarcoma refractory to doxorubicin. Material and Methods: We retrospectively evaluated seven consecutive cases of metastatic myxofibrosarcoma at our institution treated with gemcitabine-based therapy in the second-line setting, after progression on doxorubicin. Baseline clinical and baseline characteristics were collected. Primary endpoints were objective response rate (ORR), progression-free survival (PFS) and overall survival (OS). Results: After progression on first-line doxorubicin, a partial, or complete radiological response was observed in four of seven patients who received gemcitabine-based chemotherapy. With a median follow-up of 14 months, median progression-free and overall survival were 8.5 months and 11.4 months, respectively. Conclusions: Gemcitabine-based chemotherapy was associated with encouraging response rates in this cohort, similar to those seen in UPS. Both entities could be studied together for novel gemcitabine-based regimens.

scholarly journals A Phase II Nonrandomised Open-Label Study of Liposomal Daunorubicin (DaunoXome) in Advanced Soft Tissue Sarcoma

Sarcoma ◽  
2006 ◽  
Vol 2006 ◽  
pp. 1-5 ◽  
Author(s):  
Anne McTiernan ◽  
Jeremy Whelan ◽  
Michael Leahy ◽  
Penella J. Woll ◽  
Ian Judson
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Significant Activity ◽  
Open Label ◽  
Advanced Soft Tissue Sarcoma ◽  
Liposomal Daunorubicin ◽  
Open Label Study ◽  
Previously Treated ◽  
Grade 3 ◽  
Free Rate

Thirty four patients with advanced soft tissue sarcoma not previously treated with an anthracycline were treated with DaunoXome 100mg/m2 every 3 weeks. Thirty-three patients were evaluable for toxicity. Grade 3-4 neutropenia was seen in 20 patients (60.6%), complicated by febrile neutropenia in 2 (6.1%). Other grade 3 toxicities were rare. Among 32 patients assessable for response, one patient had a partial response, giving a response rate of 3.13% (95% confidence interval, 0.08–16.22%). Seven patients (21.9%) had stable disease, and 24 patients (75.0%) had disease progression. The median time to progression for all patients was 42 days (95% CI, 39–49) and the progression-free rate at 3 months was 12.5%. In conclusion, DaunoXome at this dose and schedule is well tolerated in patients with advanced soft tissue sarcoma, but is not associated with significant activity. Further studies at this dose and schedule cannot be recommended in this disease.

Cetuximab or Panitumumab versus Bevacizumab in the treatment of first line RAS wild type colorectal cancer: pooled analysis of randomized clinical trials.

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. e14634-e14634
Author(s):  
Emiliano Tamburini ◽  
Britt Rudnas ◽  
Mario Nicolini ◽  
Stefania Nicoletti ◽  
Manuela Fantini ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Pooled Analysis ◽  
Wild Type ◽  
First Line

Phase 1/2 study of safety/efficacy using trabectedin, ipilimumab and nivolumab triple therapy as first line treatment of advanced soft tissue sarcoma.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. TPS11591-TPS11591
Author(s):  
Erlinda Maria Gordon ◽  
Victoria S. Chua-Alcala ◽  
Katherine Kim ◽  
Shiva Sreenath Andrali ◽  
Marie Del Rosario ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Triple Therapy ◽  
Phase 1 ◽  
Line Treatment ◽  
First Line ◽  
Advanced Soft Tissue Sarcoma ◽  
First Line Treatment

Addition of Bevacizumab to Fluorouracil-Based First-Line Treatment of Metastatic Colorectal Cancer: Pooled Analysis of Cohorts of Older Patients From Two Randomized Clinical Trials

2009 ◽  
Vol 27 (2) ◽  
pp. 199-205 ◽  
Author(s):  
Fairooz F. Kabbinavar ◽  
Herbert I. Hurwitz ◽  
Jing Yi ◽  
Somnath Sarkar ◽  
Oliver Rosen
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Older Patients ◽  
Statistical Power ◽  
Randomized Clinical Trials ◽  
Objective Response ◽  
Progression Free Survival ◽  
Pooled Analysis ◽  
First Line ◽  
Younger Patients

PurposeColorectal cancer (CRC) occurs predominantly in older persons. To provide more statistical power to assess risk/benefit in older patients, we examined the clinical benefit of bevacizumab (BV) plus fluorouracil-based chemotherapy in first-line metastatic CRC (mCRC) treatment in patients aged ≥ 65 years, using data pooled from two placebo-controlled studies.Patients and MethodsPooled efficacy data for 439 patients ≥ 65 years old randomized to BV plus chemotherapy (n = 218) or placebo plus chemotherapy (n = 221) in study 1 and study 2 were retrospectively analyzed on an intent-to-treat basis for overall survival (OS), progression-free survival (PFS), and objective response. Safety analysis was based on reports of targeted adverse events in treated patients.ResultsMedian OS with BV plus chemotherapy was 19.3 v 14.3 months with placebo plus chemotherapy (hazard ratio [HR] = 0.70; 95% CI, 0.55 to 0.90; P = .006). Patients treated with BV plus chemotherapy had a median PFS of 9.2 v 6.2 months for placebo plus chemotherapy patients (HR = 0.52; 95% CI, 0.40 to 0.67; P < .0001). The objective response rate was 34.4% with BV plus chemotherapy versus 29.0% with placebo plus chemotherapy (difference not statistically significant). Rates of BV-associated adverse events in the pooled BV plus chemotherapy group were consistent with those reported in the overall populations for the two studies.ConclusionAnalysis of pooled patient cohorts age ≥ 65 years from two similar trials in mCRC indicates that adding bevacizumab to fluorouracil-based chemotherapy improved OS and PFS, similar to the benefits in younger patients. Also, the risks of treatment do not seem to exceed those in younger patients with mCRC.

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