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

J 2015

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 et. al.

Základní údaje

Originální název

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

Autoři

FUCHS, C. S. (840 Spojené státy), S. AZEVEDO (76 Brazílie), T. OKUSAKA (392 Japonsko), J.-L. Van LAETHEM (56 Belgie), L. R. LIPTON (36 Austrálie), H. RIESS (276 Německo), C. SZCZYLIK (616 Polsko), M. J. MOORE (124 Kanada), M. PEETERS (56 Belgie), G. BODOKY (348 Maďarsko), M. IKEDA (392 Japonsko), B. MELICHAR (203 Česká republika), Radim NĚMEČEK (203 Česká republika, garant, domácí), S. OHKAWA (392 Japonsko), A. ŚWIEBODA-SADLEJ (616 Polsko), S. A. TJULANDIN (643 Rusko), E. Van CUTSEM (56 Belgie), R. LOBERG (840 Spojené státy), V. HADDAD (826 Velká Británie a Severní Irsko), J. L. GANSERT (840 Spojené státy), B. A. BACH (826 Velká Británie a Severní Irsko) a A. CARRATO (724 Španělsko)

Vydání

Annals of Oncology, Oxford, Oxford University Press, 2015, 0923-7534

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30200 3.2 Clinical medicine

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 9.269

Kód RIV

RIV/00216224:14110/15:00087360

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1093/annonc/mdv027

UT WoS

000353830000014

Klíčová slova anglicky

ganitumab; gemcitabine; pancreatic cancer; IGF-1 receptor; biomarker

Štítky

EL OK

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 26. 4. 2016 12:21, Ing. Mgr. Věra Pospíšilíková

Anotace

V originále

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.

Citovat

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 a 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, roč. 26, č. 5, s. 921-927. ISSN 0923-7534. Dostupné z: https://dx.doi.org/10.1093/annonc/mdv027.

@article{1343561,
   author = {Fuchs, C. S. and Azevedo, S. and Okusaka, T. and Laethem, J.andL. Van and Lipton, L. R. and Riess, H. and Szczylik, C. and Moore, M. J. and Peeters, M. and Bodoky, G. and Ikeda, M. and Melichar, B. and Němeček, Radim and Ohkawa, S. and ŚwiebodaandSadlej, A. and Tjulandin, S. A. and Cutsem, E. Van and Loberg, R. and Haddad, V. and Gansert, J. L. and Bach, B. A. and Carrato, A.},
   article_location = {Oxford},
   article_number = {5},
   doi = {http://dx.doi.org/10.1093/annonc/mdv027},
   keywords = {ganitumab; gemcitabine; pancreatic cancer; IGF-1 receptor; biomarker},
   language = {eng},
   issn = {0923-7534},
   journal = {Annals of Oncology},
   title = {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},
   volume = {26},
   year = {2015}
}

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  -

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. $\backslash$'SWIEBODA-SADLEJ, S. A. TJULANDIN, E. Van CUTSEM, R. LOBERG, V. HADDAD, J. L. GANSERT, B. A. BACH a 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. \textit{Annals of Oncology}. Oxford: Oxford University Press, 2015, roč.~26, č.~5, s.~921-927. ISSN~0923-7534. Dostupné z: https://dx.doi.org/10.1093/annonc/mdv027.

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