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 language | English |
|---|---|
| Pages (from-to) | 1201-1207 |
| Number of pages | 7 |
| Journal | Annals of Oncology |
| Volume | 26 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Jun 1 2015 |
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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 journal › Article
}
TY - JOUR
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.
KW - Bevacizumab
KW - Chemotherapy
KW - Metastatic colorectal cancer
KW - Randomized clinical trial
UR - http://www.scopus.com/inward/record.url?scp=84938095204&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84938095204&partnerID=8YFLogxK
U2 - 10.1093/annonc/mdv130
DO - 10.1093/annonc/mdv130
M3 - Article
C2 - 25735317
AN - SCOPUS:84938095204
VL - 26
SP - 1201
EP - 1207
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 6
ER -