Effectiveness of bevacizumab added to standard chemotherapy in metastatic colorectal cancer: Final results for first-line treatment from the ITACa randomized clinical trial

Alessandro Passardi, O. Nanni, D. Tassinari, D. Turci, L. Cavanna, A. Fontana, S. Ruscelli, C. Mucciarini, V. Lorusso, A. Ragazzini, G. L. Frassineti, D. Amadori

Research output: Contribution to journalArticle

Abstract

Background: We report the results from a first-line phase III randomized clinical trial on metastatic colorectal cancer (mCRC) aimed at evaluating the effectiveness of adding bevacizumab (B) to standard first-line chemotherapy (CT). Patients and methods: mCRC patients were randomized to receive first-line CT (FOLFIRI or FOLFOX4) plus B (arm A) or CT only (arm B). The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), response rate (ORR) and safety. Three hundred and fifty patients and 310 events were required to have an 80% statistical power to detect a difference in PFS between the groups. Results: Between November 2007 and March 2012, 376 patients were randomized. About 60% of patients received FOLFOX4 and 40% FOLFIRI. After a median follow-up of 36 months, 343 progressions and 275 deaths had been observed in the overall population. The median PFS was 9.6 [95% confidence interval (CI) 8.2-10.3] and 8.4 (95% CI 7.2-9.0) months for arms A and B, respectively, with a hazard ratio of 0.86 (95% CI 0.70-1.07; P = 0.182). No statistically significant differences in OS or ORR were observed. B-containing regimens were associated with more frequent hypertension, bleeding, proteinuria and asthenia. Conclusions: The addition of B to standard first-line CT for mCRC did not provide a benefit in terms of PFS, OS or ORR. Further research is warranted to better identify the target population.

Original languageEnglish
Pages (from-to)1201-1207
Number of pages7
JournalAnnals of Oncology
Volume26
Issue number6
DOIs
Publication statusPublished - Jun 1 2015

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Colorectal Neoplasms
Randomized Controlled Trials
Disease-Free Survival
Drug Therapy
Confidence Intervals
Therapeutics
Asthenia
Phase III Clinical Trials
Survival
Health Services Needs and Demand
Proteinuria
Survival Rate
Bevacizumab
Hemorrhage
Hypertension
Safety
Research
Population

Keywords

  • Bevacizumab
  • Chemotherapy
  • Metastatic colorectal cancer
  • Randomized clinical trial

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

Effectiveness of bevacizumab added to standard chemotherapy in metastatic colorectal cancer : Final results for first-line treatment from the ITACa randomized clinical trial. / Passardi, Alessandro; Nanni, O.; Tassinari, D.; Turci, D.; Cavanna, L.; Fontana, A.; Ruscelli, S.; Mucciarini, C.; Lorusso, V.; Ragazzini, A.; Frassineti, G. L.; Amadori, D.

In: Annals of Oncology, Vol. 26, No. 6, 01.06.2015, p. 1201-1207.

Research output: Contribution to journalArticle

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title = "Effectiveness of bevacizumab added to standard chemotherapy in metastatic colorectal cancer: Final results for first-line treatment from the ITACa randomized clinical trial",
abstract = "Background: We report the results from a first-line phase III randomized clinical trial on metastatic colorectal cancer (mCRC) aimed at evaluating the effectiveness of adding bevacizumab (B) to standard first-line chemotherapy (CT). Patients and methods: mCRC patients were randomized to receive first-line CT (FOLFIRI or FOLFOX4) plus B (arm A) or CT only (arm B). The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), response rate (ORR) and safety. Three hundred and fifty patients and 310 events were required to have an 80{\%} statistical power to detect a difference in PFS between the groups. Results: Between November 2007 and March 2012, 376 patients were randomized. About 60{\%} of patients received FOLFOX4 and 40{\%} FOLFIRI. After a median follow-up of 36 months, 343 progressions and 275 deaths had been observed in the overall population. The median PFS was 9.6 [95{\%} confidence interval (CI) 8.2-10.3] and 8.4 (95{\%} CI 7.2-9.0) months for arms A and B, respectively, with a hazard ratio of 0.86 (95{\%} CI 0.70-1.07; P = 0.182). No statistically significant differences in OS or ORR were observed. B-containing regimens were associated with more frequent hypertension, bleeding, proteinuria and asthenia. Conclusions: The addition of B to standard first-line CT for mCRC did not provide a benefit in terms of PFS, OS or ORR. Further research is warranted to better identify the target population.",
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T1 - Effectiveness of bevacizumab added to standard chemotherapy in metastatic colorectal cancer

T2 - Final results for first-line treatment from the ITACa randomized clinical trial

AU - Passardi, Alessandro

AU - Nanni, O.

AU - Tassinari, D.

AU - Turci, D.

AU - Cavanna, L.

AU - Fontana, A.

AU - Ruscelli, S.

AU - Mucciarini, C.

AU - Lorusso, V.

AU - Ragazzini, A.

AU - Frassineti, G. L.

AU - Amadori, D.

PY - 2015/6/1

Y1 - 2015/6/1

N2 - Background: We report the results from a first-line phase III randomized clinical trial on metastatic colorectal cancer (mCRC) aimed at evaluating the effectiveness of adding bevacizumab (B) to standard first-line chemotherapy (CT). Patients and methods: mCRC patients were randomized to receive first-line CT (FOLFIRI or FOLFOX4) plus B (arm A) or CT only (arm B). The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), response rate (ORR) and safety. Three hundred and fifty patients and 310 events were required to have an 80% statistical power to detect a difference in PFS between the groups. Results: Between November 2007 and March 2012, 376 patients were randomized. About 60% of patients received FOLFOX4 and 40% FOLFIRI. After a median follow-up of 36 months, 343 progressions and 275 deaths had been observed in the overall population. The median PFS was 9.6 [95% confidence interval (CI) 8.2-10.3] and 8.4 (95% CI 7.2-9.0) months for arms A and B, respectively, with a hazard ratio of 0.86 (95% CI 0.70-1.07; P = 0.182). No statistically significant differences in OS or ORR were observed. B-containing regimens were associated with more frequent hypertension, bleeding, proteinuria and asthenia. Conclusions: The addition of B to standard first-line CT for mCRC did not provide a benefit in terms of PFS, OS or ORR. Further research is warranted to better identify the target population.

AB - Background: We report the results from a first-line phase III randomized clinical trial on metastatic colorectal cancer (mCRC) aimed at evaluating the effectiveness of adding bevacizumab (B) to standard first-line chemotherapy (CT). Patients and methods: mCRC patients were randomized to receive first-line CT (FOLFIRI or FOLFOX4) plus B (arm A) or CT only (arm B). The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), response rate (ORR) and safety. Three hundred and fifty patients and 310 events were required to have an 80% statistical power to detect a difference in PFS between the groups. Results: Between November 2007 and March 2012, 376 patients were randomized. About 60% of patients received FOLFOX4 and 40% FOLFIRI. After a median follow-up of 36 months, 343 progressions and 275 deaths had been observed in the overall population. The median PFS was 9.6 [95% confidence interval (CI) 8.2-10.3] and 8.4 (95% CI 7.2-9.0) months for arms A and B, respectively, with a hazard ratio of 0.86 (95% CI 0.70-1.07; P = 0.182). No statistically significant differences in OS or ORR were observed. B-containing regimens were associated with more frequent hypertension, bleeding, proteinuria and asthenia. Conclusions: The addition of B to standard first-line CT for mCRC did not provide a benefit in terms of PFS, OS or ORR. Further research is warranted to better identify the target population.

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KW - Chemotherapy

KW - Metastatic colorectal cancer

KW - Randomized clinical trial

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U2 - 10.1093/annonc/mdv130

DO - 10.1093/annonc/mdv130

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