Abstract
Background. The phase II YO28252 study (NCT01590719) examined first-line onartuzumab plus mFOLFOX6 in patients with metastatic, human epidermal growth factor receptor 2-negative adenocarcinoma of the stomach or gastroesophageal junction. MET immunohistochemistry expression as a biomarker of onartuzumab activity was also examined. Patients and Methods. Patients were randomized 1:1 to receive standard mFOLFOX6 plus onartuzumab (10 mg/kg) or placebo in 2-week cycles for 12 cycles,followed by onartuzumab or placebo until disease progression. Coprimary endpoints were progression-free survival (PFS) in intent-to-treat (ITT) and MET-positive populations. The target hazard ratio (HR) was 0.70 for patients in the ITT group and0.60 in the MET-positive population. Secondary end points were overall survival (OS), overall response rate (ORR), and safety. Results. Overall, 123patients were enrolled (n562onartuzumab, n 5 61 placebo). Median PFS was 6.77 versus 6.97 months for onartuzumab versus placebo, respectively (HR, 1.08; 95% confidence interval [CI], 0.71–1.63; p 5 = 71). In the MET-positive population, median PFS was 5.95 versus 6.80months, onartuzumab versus placebo (HR, 1.38; 95% CI, 0.60–3.20; p5.45).Median OS was 10.61 months for onartuzumab versus 11.27 months for placebo) (HR, 1.06, 0.64–1.75; p 5 =.83). In the MET-positive population, median OS was 8.51 versus 8.48 months for onartuzumab versus placebo, respectively (HR, 1.12, 95% CI, 0.45–2.78; p 5=.80). ORR was 60.5% for the onartuzumab group and 57.1%for placebo. Grade3–5adver see vents (AEs) wereseenin 88.3% of patients receiving onartuzumab and in 78.3% of patients receiving placebo, with serious AEs in 55% and 40%, respectively. Conclusion. Theaddition of onartuzumab to mFOLFOX6 ingastric cancer did not improve efficacy in an unselected population orin a MET immunohistochemistry-positive population.
| Original language | English |
|---|---|
| Pages (from-to) | 1085-1090 |
| Number of pages | 6 |
| Journal | Oncologist |
| Volume | 21 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - 2016 Sep 1 |
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All Science Journal Classification (ASJC) codes
- Oncology
- Cancer Research
Cite this
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A randomized phase II study of FOLFOX with or without the MET inhibitor onartuzumab in advanced Adenocarcinoma of the stomach and Gastroesophageal junction. / Shah, Manish A.; Cho, Jae Yong; Tan, Iain B.; Tebbutt, Niall C.; Yen, Chia-Jui; Kang, Alice; Shames, David S.; Bu, Lilian; Kang, Yoon Koo.
In: Oncologist, Vol. 21, No. 9, 01.09.2016, p. 1085-1090.Research output: Contribution to journal › Article
TY - JOUR
T1 - A randomized phase II study of FOLFOX with or without the MET inhibitor onartuzumab in advanced Adenocarcinoma of the stomach and Gastroesophageal junction
AU - Shah, Manish A.
AU - Cho, Jae Yong
AU - Tan, Iain B.
AU - Tebbutt, Niall C.
AU - Yen, Chia-Jui
AU - Kang, Alice
AU - Shames, David S.
AU - Bu, Lilian
AU - Kang, Yoon Koo
PY - 2016/9/1
Y1 - 2016/9/1
N2 - Background. The phase II YO28252 study (NCT01590719) examined first-line onartuzumab plus mFOLFOX6 in patients with metastatic, human epidermal growth factor receptor 2-negative adenocarcinoma of the stomach or gastroesophageal junction. MET immunohistochemistry expression as a biomarker of onartuzumab activity was also examined. Patients and Methods. Patients were randomized 1:1 to receive standard mFOLFOX6 plus onartuzumab (10 mg/kg) or placebo in 2-week cycles for 12 cycles,followed by onartuzumab or placebo until disease progression. Coprimary endpoints were progression-free survival (PFS) in intent-to-treat (ITT) and MET-positive populations. The target hazard ratio (HR) was 0.70 for patients in the ITT group and0.60 in the MET-positive population. Secondary end points were overall survival (OS), overall response rate (ORR), and safety. Results. Overall, 123patients were enrolled (n562onartuzumab, n 5 61 placebo). Median PFS was 6.77 versus 6.97 months for onartuzumab versus placebo, respectively (HR, 1.08; 95% confidence interval [CI], 0.71–1.63; p 5 = 71). In the MET-positive population, median PFS was 5.95 versus 6.80months, onartuzumab versus placebo (HR, 1.38; 95% CI, 0.60–3.20; p5.45).Median OS was 10.61 months for onartuzumab versus 11.27 months for placebo) (HR, 1.06, 0.64–1.75; p 5 =.83). In the MET-positive population, median OS was 8.51 versus 8.48 months for onartuzumab versus placebo, respectively (HR, 1.12, 95% CI, 0.45–2.78; p 5=.80). ORR was 60.5% for the onartuzumab group and 57.1%for placebo. Grade3–5adver see vents (AEs) wereseenin 88.3% of patients receiving onartuzumab and in 78.3% of patients receiving placebo, with serious AEs in 55% and 40%, respectively. Conclusion. Theaddition of onartuzumab to mFOLFOX6 ingastric cancer did not improve efficacy in an unselected population orin a MET immunohistochemistry-positive population.
AB - Background. The phase II YO28252 study (NCT01590719) examined first-line onartuzumab plus mFOLFOX6 in patients with metastatic, human epidermal growth factor receptor 2-negative adenocarcinoma of the stomach or gastroesophageal junction. MET immunohistochemistry expression as a biomarker of onartuzumab activity was also examined. Patients and Methods. Patients were randomized 1:1 to receive standard mFOLFOX6 plus onartuzumab (10 mg/kg) or placebo in 2-week cycles for 12 cycles,followed by onartuzumab or placebo until disease progression. Coprimary endpoints were progression-free survival (PFS) in intent-to-treat (ITT) and MET-positive populations. The target hazard ratio (HR) was 0.70 for patients in the ITT group and0.60 in the MET-positive population. Secondary end points were overall survival (OS), overall response rate (ORR), and safety. Results. Overall, 123patients were enrolled (n562onartuzumab, n 5 61 placebo). Median PFS was 6.77 versus 6.97 months for onartuzumab versus placebo, respectively (HR, 1.08; 95% confidence interval [CI], 0.71–1.63; p 5 = 71). In the MET-positive population, median PFS was 5.95 versus 6.80months, onartuzumab versus placebo (HR, 1.38; 95% CI, 0.60–3.20; p5.45).Median OS was 10.61 months for onartuzumab versus 11.27 months for placebo) (HR, 1.06, 0.64–1.75; p 5 =.83). In the MET-positive population, median OS was 8.51 versus 8.48 months for onartuzumab versus placebo, respectively (HR, 1.12, 95% CI, 0.45–2.78; p 5=.80). ORR was 60.5% for the onartuzumab group and 57.1%for placebo. Grade3–5adver see vents (AEs) wereseenin 88.3% of patients receiving onartuzumab and in 78.3% of patients receiving placebo, with serious AEs in 55% and 40%, respectively. Conclusion. Theaddition of onartuzumab to mFOLFOX6 ingastric cancer did not improve efficacy in an unselected population orin a MET immunohistochemistry-positive population.
UR - http://www.scopus.com/inward/record.url?scp=84988025815&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84988025815&partnerID=8YFLogxK
U2 - 10.1634/theoncologist.2016-0038
DO - 10.1634/theoncologist.2016-0038
M3 - Article
C2 - 27401892
AN - SCOPUS:84988025815
VL - 21
SP - 1085
EP - 1090
JO - Oncologist
JF - Oncologist
SN - 1083-7159
IS - 9
ER -