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Phase II Trial of Gemcitabine and Docetaxel with Bevacizumab in Soft Tissue Sarcoma.

Dickson MA, D'Adamo DR, Keohan ML, D'Angelo SP, Carvajal RD, Gounder MM, Maki RG, Qin LX, Lefkowitz RA, McKennon OR, Hirst CM, Schwartz GK, Tap WD - Sarcoma (2015)

Bottom Line: This study tested the hypothesis that outcomes would be improved by addition of bevacizumab (B).Of 44 patients enrolled, 35 were treated with GDB and evaluable for safety and efficacy.However PFS at 3 m (76%) was promising and response rate was higher than expected from G + D.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.

ABSTRACT
Gemcitabine (G) and docetaxel (D) are commonly used to treat recurrent/metastatic soft tissue sarcoma. This study tested the hypothesis that outcomes would be improved by addition of bevacizumab (B). The initial design was randomized double-blind trial of G + D + B versus G + D + placebo. Due to slow accrual this was modified to single-arm open-label G + D + B. Eligible patients had diagnosis of leiomyosarcoma, pleomorphic undifferentiated sarcoma, pleomorphic liposarcoma, or angiosarcoma. Treatment was B 15 mg/kg on d1, G 900 mg/m(2) on d1 and d8, and D 75 mg/m(2) on d8, q21d. Primary endpoint was progression-free survival (PFS) at 6 months and would be met if ≥17 patients were progression-free at 6 m. Secondary endpoints are response rate, PFS at 3 m, overall survival, and toxicity. Of 44 patients enrolled, 35 were treated with GDB and evaluable for safety and efficacy. Median age was 55, 50% male, most ECOG 0. Toxicity is mostly myelosuppression with one deep vein thrombosis and one small bowel perforation possibly related to B. There were 17 partial responses (49%) by RECIST 1.1. Among 35 patients, the number who remained on study and progression-free was 24 at 3 m and 15 at 6 m. 9 withdrew prior to 6 m for reasons other than toxicity or progression. PFS at 6 m was 65% (95% CI: 51-85%). The primary endpoint of 6 m PFS was not met due to censoring of patients who withdrew. However PFS at 3 m (76%) was promising and response rate was higher than expected from G + D.

No MeSH data available.


Related in: MedlinePlus

Waterfall plot showing tumor response in patients treated with gemcitabine + docetaxel + bevacizumab.
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Related In: Results  -  Collection


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fig2: Waterfall plot showing tumor response in patients treated with gemcitabine + docetaxel + bevacizumab.

Mentions: Of 35 patients, there were 17 partial responses, for an overall response rate of 49% (95% CI 31–66%). Responses were seen in all histologies: leiomyosarcoma (8/17 = 47%), undifferentiated pleomorphic sarcoma (5/11 = 45%), angiosarcoma (3/5 = 60%), and pleomorphic liposarcoma (1/1). Within the leiomyosarcoma group, 2/5 patients with uterine leiomyosarcoma had partial responses. In addition to the 17 partial responses, 9 patients had decrease in target lesions of at least 10% but not sufficient to meet criteria for PR. The best response by RECIST for each evaluable patient is shown in a waterfall plot in Figure 2.


Phase II Trial of Gemcitabine and Docetaxel with Bevacizumab in Soft Tissue Sarcoma.

Dickson MA, D'Adamo DR, Keohan ML, D'Angelo SP, Carvajal RD, Gounder MM, Maki RG, Qin LX, Lefkowitz RA, McKennon OR, Hirst CM, Schwartz GK, Tap WD - Sarcoma (2015)

Waterfall plot showing tumor response in patients treated with gemcitabine + docetaxel + bevacizumab.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4446476&req=5

fig2: Waterfall plot showing tumor response in patients treated with gemcitabine + docetaxel + bevacizumab.
Mentions: Of 35 patients, there were 17 partial responses, for an overall response rate of 49% (95% CI 31–66%). Responses were seen in all histologies: leiomyosarcoma (8/17 = 47%), undifferentiated pleomorphic sarcoma (5/11 = 45%), angiosarcoma (3/5 = 60%), and pleomorphic liposarcoma (1/1). Within the leiomyosarcoma group, 2/5 patients with uterine leiomyosarcoma had partial responses. In addition to the 17 partial responses, 9 patients had decrease in target lesions of at least 10% but not sufficient to meet criteria for PR. The best response by RECIST for each evaluable patient is shown in a waterfall plot in Figure 2.

Bottom Line: This study tested the hypothesis that outcomes would be improved by addition of bevacizumab (B).Of 44 patients enrolled, 35 were treated with GDB and evaluable for safety and efficacy.However PFS at 3 m (76%) was promising and response rate was higher than expected from G + D.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.

ABSTRACT
Gemcitabine (G) and docetaxel (D) are commonly used to treat recurrent/metastatic soft tissue sarcoma. This study tested the hypothesis that outcomes would be improved by addition of bevacizumab (B). The initial design was randomized double-blind trial of G + D + B versus G + D + placebo. Due to slow accrual this was modified to single-arm open-label G + D + B. Eligible patients had diagnosis of leiomyosarcoma, pleomorphic undifferentiated sarcoma, pleomorphic liposarcoma, or angiosarcoma. Treatment was B 15 mg/kg on d1, G 900 mg/m(2) on d1 and d8, and D 75 mg/m(2) on d8, q21d. Primary endpoint was progression-free survival (PFS) at 6 months and would be met if ≥17 patients were progression-free at 6 m. Secondary endpoints are response rate, PFS at 3 m, overall survival, and toxicity. Of 44 patients enrolled, 35 were treated with GDB and evaluable for safety and efficacy. Median age was 55, 50% male, most ECOG 0. Toxicity is mostly myelosuppression with one deep vein thrombosis and one small bowel perforation possibly related to B. There were 17 partial responses (49%) by RECIST 1.1. Among 35 patients, the number who remained on study and progression-free was 24 at 3 m and 15 at 6 m. 9 withdrew prior to 6 m for reasons other than toxicity or progression. PFS at 6 m was 65% (95% CI: 51-85%). The primary endpoint of 6 m PFS was not met due to censoring of patients who withdrew. However PFS at 3 m (76%) was promising and response rate was higher than expected from G + D.

No MeSH data available.


Related in: MedlinePlus