A phase 3 randomized, double-blind, placebo-controlled trial of
ganitumab or placebo in combination with gemcitabine as
first-line therapy for metastatic adenocarcinoma of the
pancreas: the GAMMA trial

FUCHS, C. S., S. AZEVEDO, T. OKUSAKA, J.-L. Van LAETHEM, L. R. LIPTON, H. RIESS, C. SZCZYLIK, M. J. MOORE, M. PEETERS, G. BODOKY, M. IKEDA, B. MELICHAR, Radim NĚMEČEK, S. OHKAWA, A. ŚWIEBODA-SADLEJ, S. A. TJULANDIN, E. Van CUTSEM, R. LOBERG, V. HADDAD, J. L. GANSERT, B. A. BACH and A. CARRATO. A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. Annals of Oncology. Oxford: Oxford University Press, 2015, vol. 26, No 5, p. 921-927. ISSN 0923-7534. Available from: https://dx.doi.org/10.1093/annonc/mdv027.

Other formats: BibTeX LaTeX RIS

TY  - JOUR
ID  - 1343561
AU  - Fuchs, C. S. - Azevedo, S. - Okusaka, T. - Laethem, J.-L. Van - Lipton, L. R. - Riess, H. - Szczylik, C. - Moore, M. J. - Peeters, M. - Bodoky, G. - Ikeda, M. - Melichar, B. - Němeček, Radim - Ohkawa, S. - Świeboda-Sadlej, A. - Tjulandin, S. A. - Cutsem, E. Van - Loberg, R. - Haddad, V. - Gansert, J. L. - Bach, B. A. - Carrato, A.
PY  - 2015
TI  - A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial
JF  - Annals of Oncology
VL  - 26
IS  - 5
SP  - 921-927
EP  - 921-927
PB  - Oxford University Press
SN  - 09237534
KW  - ganitumab
KW  - gemcitabine
KW  - pancreatic cancer
KW  - IGF-1 receptor
KW  - biomarker
N2  - Background: This double-blind, phase 3 study assessed the efficacy and safety of ganitumab combined with gemcitabine as first-line treatment of metastatic pancreatic cancer. Patients and methods: Patients with previously untreated metastatic pancreatic adenocarcinoma were randomly assigned 2 : 2 : 1 to receive intravenous gemcitabine 1000 mg/m(2) (days 1, 8, and 15 of each 28-day cycle) plus placebo, ganitumab 12 mg/kg, or ganitumab 20 mg/kg (days 1 and 15 of each cycle). The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), safety, and efficacy by levels of circulating biomarkers. Results: Overall, 322 patients were randomly assigned to placebo, 318 to ganitumab 12 mg/kg, and 160 to ganitumab 20 mg/kg. The study was stopped based on results from a preplanned futility analysis; the final results are reported. Median OS was 7.2 months [95% confidence interval (CI), 6.3-8.2] in the placebo arm, 7.0 months (95% CI, 6.2-8.5) in the ganitumab 12-mg/kg arm [hazard ratio (HR), 1.00; 95% CI, 0.82-1.21; P = 0.494], and 7.1 months (95% CI, 6.4-8.5) in the ganitumab 20-mg/kg arm (HR, 0.97; 95% CI, 0.76-1.23; P = 0.397). Median PFS was 3.7, 3.6 (HR, 1.00; 95% CI, 0.84-1.20; P = 0.520), and 3.7 months (HR, 0.97; 95% CI, 0.77-1.22; P = 0.403), respectively. No unexpected toxicity was observed with ganitumab plus gemcitabine. The circulating biomarkers assessed [insulin-like growth factor-1 (IGF-1), IGF-binding protein-2, and -3] were not associated with a treatment effect on OS or PFS by ganitumab. Conclusion: Ganitumab combined with gemcitabine had manageable toxicity but did not improve OS, compared with gemcitabine alone in unselected patients with metastatic pancreatic cancer.
ER  -

Basic information
Original name	A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial
Authors	FUCHS, C. S. (840 United States of America), S. AZEVEDO (76 Brazil), T. OKUSAKA (392 Japan), J.-L. Van LAETHEM (56 Belgium), L. R. LIPTON (36 Australia), H. RIESS (276 Germany), C. SZCZYLIK (616 Poland), M. J. MOORE (124 Canada), M. PEETERS (56 Belgium), G. BODOKY (348 Hungary), M. IKEDA (392 Japan), B. MELICHAR (203 Czech Republic), Radim NĚMEČEK (203 Czech Republic, guarantor, belonging to the institution), S. OHKAWA (392 Japan), A. ŚWIEBODA-SADLEJ (616 Poland), S. A. TJULANDIN (643 Russian Federation), E. Van CUTSEM (56 Belgium), R. LOBERG (840 United States of America), V. HADDAD (826 United Kingdom of Great Britain and Northern Ireland), J. L. GANSERT (840 United States of America), B. A. BACH (826 United Kingdom of Great Britain and Northern Ireland) and A. CARRATO (724 Spain).
Edition	Annals of Oncology, Oxford, Oxford University Press, 2015, 0923-7534.

Other information
Original language	English
Type of outcome	Article in a journal
Field of Study	30200 3.2 Clinical medicine
Country of publisher	United Kingdom of Great Britain and Northern Ireland
Confidentiality degree	is not subject to a state or trade secret
Impact factor	Impact factor: 9.269
RIV identification code	RIV/00216224:14110/15:00087360
Organization unit	Faculty of Medicine
Doi	http://dx.doi.org/10.1093/annonc/mdv027
UT WoS	000353830000014
Keywords in English	ganitumab; gemcitabine; pancreatic cancer; IGF-1 receptor; biomarker
Tags	EL OK
Tags	International impact, Reviewed
Changed by	Changed by: Ing. Mgr. Věra Pospíšilíková, učo 9005. Changed: 26/4/2016 12:21.

Abstract

Background: This double-blind, phase 3 study assessed the efficacy and safety of ganitumab combined with gemcitabine as first-line treatment of metastatic pancreatic cancer. Patients and methods: Patients with previously untreated metastatic pancreatic adenocarcinoma were randomly assigned 2 : 2 : 1 to receive intravenous gemcitabine 1000 mg/m(2) (days 1, 8, and 15 of each 28-day cycle) plus placebo, ganitumab 12 mg/kg, or ganitumab 20 mg/kg (days 1 and 15 of each cycle). The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), safety, and efficacy by levels of circulating biomarkers. Results: Overall, 322 patients were randomly assigned to placebo, 318 to ganitumab 12 mg/kg, and 160 to ganitumab 20 mg/kg. The study was stopped based on results from a preplanned futility analysis; the final results are reported. Median OS was 7.2 months [95% confidence interval (CI), 6.3-8.2] in the placebo arm, 7.0 months (95% CI, 6.2-8.5) in the ganitumab 12-mg/kg arm [hazard ratio (HR), 1.00; 95% CI, 0.82-1.21; P = 0.494], and 7.1 months (95% CI, 6.4-8.5) in the ganitumab 20-mg/kg arm (HR, 0.97; 95% CI, 0.76-1.23; P = 0.397). Median PFS was 3.7, 3.6 (HR, 1.00; 95% CI, 0.84-1.20; P = 0.520), and 3.7 months (HR, 0.97; 95% CI, 0.77-1.22; P = 0.403), respectively. No unexpected toxicity was observed with ganitumab plus gemcitabine. The circulating biomarkers assessed [insulin-like growth factor-1 (IGF-1), IGF-binding protein-2, and -3] were not associated with a treatment effect on OS or PFS by ganitumab. Conclusion: Ganitumab combined with gemcitabine had manageable toxicity but did not improve OS, compared with gemcitabine alone in unselected patients with metastatic pancreatic cancer.

PrintDisplayed: 3/5/2024 11:24

A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination ...

Other applications