A phase 2 study of temsirolimus (CCI-779) in patients with soft tissue sarcomas: A study of the mayo phase 2 Consortium (P2C)

Scott Heitaka Okuno, Howard Bailey, Michelle R. Mahoney, Douglas Adkins, William Maples, Tom Fitch, David Ettinger, Charles Erlichman, Jann N Sarkaria

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: The primary goal of this trial was to evaluate the confirmed response rate of temsirolimus (CCI-779), a mammalian target of rapamycin in patients with advanced soft tissue sarcomas (STS). METHODS: Patients ≥18 years with measurable advanced STS, no prior chemotherapy for metastatic disease (adjuvant and neoadjuvant chemotherapy allowed), adequate organ function, and performance status of ≤2 were eligible. After premedication with an antihistamine, CCI-779 was given intravenously at 25 mg over 30 minutes on Days 1, 8, 15, and 22, repeated every 4 weeks. The primary endpoint was confirmed response rate per Response Evaluation Criteria in Solid Tumors. RESULTS: Between June 2004 and November 2005, a total of 41 patients were enrolled and began treatment; 40 patients are evaluable for response and adverse events. The median age was 62 years (range, 28-72 years) with 56% women. Eighty percent had high-grade STS, and 22% had prior adjuvant chemotherapy. There were 2 patients (5%; 95% confidence interval [CI], 1-17) (undifferentiated fibrosarcoma and uterine leiomyosarcoma) who achieved a confirmed partial response lasting 3 and 17 months, respectively. Thirty-nine (95%) patients have progressed, with a median time to progression of 2.0 months (95% CI, 1.8-3.5). The median overall survival was 7.6 months (95% CI, 6.1-15.9). Forty-three percent experienced grade 3+ adverse events that were possibly related to therapy. CONCLUSIONS: Temsirolimus in this patient population of STS had limited clinical activity and had moderate toxicities.

Original languageEnglish (US)
Pages (from-to)3468-3475
Number of pages8
JournalCancer
Volume117
Issue number15
DOIs
StatePublished - Aug 1 2011

Fingerprint

Sarcoma
Confidence Intervals
Adjuvant Chemotherapy
Leiomyosarcoma
Premedication
Fibrosarcoma
Histamine Antagonists
Sirolimus
temsirolimus
Drug Therapy
Survival
Therapeutics
Population

Keywords

  • mammalian target of rapamycin
  • soft tissue sarcoma
  • temsirolimus
  • toxicities

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

A phase 2 study of temsirolimus (CCI-779) in patients with soft tissue sarcomas : A study of the mayo phase 2 Consortium (P2C). / Okuno, Scott Heitaka; Bailey, Howard; Mahoney, Michelle R.; Adkins, Douglas; Maples, William; Fitch, Tom; Ettinger, David; Erlichman, Charles; Sarkaria, Jann N.

In: Cancer, Vol. 117, No. 15, 01.08.2011, p. 3468-3475.

Research output: Contribution to journalArticle

Okuno, SH, Bailey, H, Mahoney, MR, Adkins, D, Maples, W, Fitch, T, Ettinger, D, Erlichman, C & Sarkaria, JN 2011, 'A phase 2 study of temsirolimus (CCI-779) in patients with soft tissue sarcomas: A study of the mayo phase 2 Consortium (P2C)', Cancer, vol. 117, no. 15, pp. 3468-3475. https://doi.org/10.1002/cncr.25928
Okuno, Scott Heitaka ; Bailey, Howard ; Mahoney, Michelle R. ; Adkins, Douglas ; Maples, William ; Fitch, Tom ; Ettinger, David ; Erlichman, Charles ; Sarkaria, Jann N. / A phase 2 study of temsirolimus (CCI-779) in patients with soft tissue sarcomas : A study of the mayo phase 2 Consortium (P2C). In: Cancer. 2011 ; Vol. 117, No. 15. pp. 3468-3475.
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abstract = "BACKGROUND: The primary goal of this trial was to evaluate the confirmed response rate of temsirolimus (CCI-779), a mammalian target of rapamycin in patients with advanced soft tissue sarcomas (STS). METHODS: Patients ≥18 years with measurable advanced STS, no prior chemotherapy for metastatic disease (adjuvant and neoadjuvant chemotherapy allowed), adequate organ function, and performance status of ≤2 were eligible. After premedication with an antihistamine, CCI-779 was given intravenously at 25 mg over 30 minutes on Days 1, 8, 15, and 22, repeated every 4 weeks. The primary endpoint was confirmed response rate per Response Evaluation Criteria in Solid Tumors. RESULTS: Between June 2004 and November 2005, a total of 41 patients were enrolled and began treatment; 40 patients are evaluable for response and adverse events. The median age was 62 years (range, 28-72 years) with 56{\%} women. Eighty percent had high-grade STS, and 22{\%} had prior adjuvant chemotherapy. There were 2 patients (5{\%}; 95{\%} confidence interval [CI], 1-17) (undifferentiated fibrosarcoma and uterine leiomyosarcoma) who achieved a confirmed partial response lasting 3 and 17 months, respectively. Thirty-nine (95{\%}) patients have progressed, with a median time to progression of 2.0 months (95{\%} CI, 1.8-3.5). The median overall survival was 7.6 months (95{\%} CI, 6.1-15.9). Forty-three percent experienced grade 3+ adverse events that were possibly related to therapy. CONCLUSIONS: Temsirolimus in this patient population of STS had limited clinical activity and had moderate toxicities.",
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AU - Mahoney, Michelle R.

AU - Adkins, Douglas

AU - Maples, William

AU - Fitch, Tom

AU - Ettinger, David

AU - Erlichman, Charles

AU - Sarkaria, Jann N

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N2 - BACKGROUND: The primary goal of this trial was to evaluate the confirmed response rate of temsirolimus (CCI-779), a mammalian target of rapamycin in patients with advanced soft tissue sarcomas (STS). METHODS: Patients ≥18 years with measurable advanced STS, no prior chemotherapy for metastatic disease (adjuvant and neoadjuvant chemotherapy allowed), adequate organ function, and performance status of ≤2 were eligible. After premedication with an antihistamine, CCI-779 was given intravenously at 25 mg over 30 minutes on Days 1, 8, 15, and 22, repeated every 4 weeks. The primary endpoint was confirmed response rate per Response Evaluation Criteria in Solid Tumors. RESULTS: Between June 2004 and November 2005, a total of 41 patients were enrolled and began treatment; 40 patients are evaluable for response and adverse events. The median age was 62 years (range, 28-72 years) with 56% women. Eighty percent had high-grade STS, and 22% had prior adjuvant chemotherapy. There were 2 patients (5%; 95% confidence interval [CI], 1-17) (undifferentiated fibrosarcoma and uterine leiomyosarcoma) who achieved a confirmed partial response lasting 3 and 17 months, respectively. Thirty-nine (95%) patients have progressed, with a median time to progression of 2.0 months (95% CI, 1.8-3.5). The median overall survival was 7.6 months (95% CI, 6.1-15.9). Forty-three percent experienced grade 3+ adverse events that were possibly related to therapy. CONCLUSIONS: Temsirolimus in this patient population of STS had limited clinical activity and had moderate toxicities.

AB - BACKGROUND: The primary goal of this trial was to evaluate the confirmed response rate of temsirolimus (CCI-779), a mammalian target of rapamycin in patients with advanced soft tissue sarcomas (STS). METHODS: Patients ≥18 years with measurable advanced STS, no prior chemotherapy for metastatic disease (adjuvant and neoadjuvant chemotherapy allowed), adequate organ function, and performance status of ≤2 were eligible. After premedication with an antihistamine, CCI-779 was given intravenously at 25 mg over 30 minutes on Days 1, 8, 15, and 22, repeated every 4 weeks. The primary endpoint was confirmed response rate per Response Evaluation Criteria in Solid Tumors. RESULTS: Between June 2004 and November 2005, a total of 41 patients were enrolled and began treatment; 40 patients are evaluable for response and adverse events. The median age was 62 years (range, 28-72 years) with 56% women. Eighty percent had high-grade STS, and 22% had prior adjuvant chemotherapy. There were 2 patients (5%; 95% confidence interval [CI], 1-17) (undifferentiated fibrosarcoma and uterine leiomyosarcoma) who achieved a confirmed partial response lasting 3 and 17 months, respectively. Thirty-nine (95%) patients have progressed, with a median time to progression of 2.0 months (95% CI, 1.8-3.5). The median overall survival was 7.6 months (95% CI, 6.1-15.9). Forty-three percent experienced grade 3+ adverse events that were possibly related to therapy. CONCLUSIONS: Temsirolimus in this patient population of STS had limited clinical activity and had moderate toxicities.

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