Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results from a Randomized, Open-Label, Phase III Trial

M. A. Tempero; U. Pelzer; E. M. O'Reilly; J. Winter; D. -Y. Oh; C. -P. Li; Giampaolo Tortora; H. -M. Chang; C. D. Lopez; T. Bekaii-Saab; A. H. Ko; A. Santoro; J. O. Park; M. S. Noel; G. L. Frassineti; Y. -S. Shan; A. Dean; H. Riess; E. Van Cutsem; J. Berlin; P. Philip; M. Moore; D. Goldstein; J. Tabernero; M. Li; S. Ferrara; Y. Le Bruchec; G. Zhang; B. Lu; A. V. Biankin; M. Reni; R. Epstein; P. Vasey; J. Shapiro; M. Burge; Y. J. Chua; M. Harris; N. Pavlakis; N. Tebbutt; G. Prager; C. Dittrich; F. Langle; K. Philipp-Abbrederis; R. Greil; H. Stoger; M. Girschikofsky; T. Kuehr; J. -L. Van Laethem; S. Laurent; N. Dhani; Y. J. Ko; S. Dowden; P. Kavan; M. E. Tehfe; E. Kubala; M. Kohoutek; P. Pfeiffer; M. Yilmaz; V. Parner; T. Salminen; L. -M. Soveri; E. Korkeila; P. Osterlund; J. Taieb; D. Tougeron; P. Artru; F. X. Caroli-Bosc; R. Guimbaud; A. Turpin; T. Walter; J. B. Bachet; V. Kunzmann; F. Kreth; A. Block; M. Venerito; H. Oettle; M. Karthaus; J. Trojan; G. Folprecht; M. Lerch; F. Kullmann; M. Reiser; V. Heinemann; M. -A. Worns; H. Schulz; B. Garlipp; T. Yau; L. S. Chan; B. Juhasz; L. Landherr; T. Pinter; G. Bodoky; Z. Kahan; R. Mcdermott; D. Power; Leonardo Gianni; S. Siena; M. Milella; A. Falcone; R. Berardi; C. Bagala; F. Di Costanzo; F. Roila; A. Ardizzoni; Emanuela Maiello; S. Fanello; J. Wilmink; J. Willem De Groot; G. Creemers; E. Barroso; T. Rodrigues; C. Sarmento; C. E. Chee; D. Tai; T. M. Mercade; M. H. Medina; A. C. Mena; J. M. Santasusana; M. J. Flor Oncala; C. G. Martin; R. Lopez; A. Munoz; R. V. Garcia; I. Ales; B. L. Saez; F. Rivera; J. Sastre; C. -C. Wu; Y. -W. Tien; D. -C. Chan; T. -L. Hwang; J. Evans; J. Wadsley; P. Corrie; A. Biankin; A. Ko; D. Cardin; E. Chiorean; J. Bendell; A. Noonan; H. Kindler; N. Fernando; M. Beg; T. George; M. Noel; N. Loconte; F. Arena; J. Posey; R. Malhotra; C. Lopez; D. Sohal; R. Mcwilliams; W. Brenner; M. Womack; R. Seth; R. Lyer; N. Bahary; R. Marsh; R. Ramirez; C. Chua; J. Reeves; G. Manji; A. El-Khoueiry; R. Weaver; V. Sahai; W. Messersmith; R. Dreicer; A. Zakari; A. Bullock; B. Musher; M. Borad; E. Kim; D. Bajor; T. Huyck; H. Hatoum; H. Xiong; B. Pasche; J. Lacy; O. Olowokure; A. Cohn; D. Richards; R. Martin; A. Paulson; P. Fanta; S. Krishnamurthi; P. Oberstein; J. Fuloria

doi:10.1200/JCO.22.01134

Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results from a Randomized, Open-Label, Phase III Trial

M. A. Tempero, U. Pelzer, E. M. O'Reilly, J. Winter, D. -Y. Oh, C. -P. Li, Giampaolo Tortora, H. -M. Chang, C. D. Lopez, T. Bekaii-Saab, A. H. Ko, A. Santoro, J. O. Park, M. S. Noel, G. L. Frassineti, Y. -S. Shan, A. Dean, H. Riess, E. Van Cutsem, J. BerlinP. Philip, M. Moore, D. Goldstein, J. Tabernero, M. Li, S. Ferrara, Y. Le Bruchec, G. Zhang, B. Lu, A. V. Biankin, M. Reni, R. Epstein, P. Vasey, J. Shapiro, M. Burge, Y. J. Chua, M. Harris, N. Pavlakis, N. Tebbutt, G. Prager, C. Dittrich, F. Langle, K. Philipp-Abbrederis, R. Greil, H. Stoger, M. Girschikofsky, T. Kuehr, J. -L. Van Laethem, S. Laurent, N. Dhani, Y. J. Ko, S. Dowden, P. Kavan, M. E. Tehfe, E. Kubala, M. Kohoutek, P. Pfeiffer, M. Yilmaz, V. Parner, T. Salminen, L. -M. Soveri, E. Korkeila, P. Osterlund, J. Taieb, D. Tougeron, P. Artru, F. X. Caroli-Bosc, R. Guimbaud, A. Turpin, T. Walter, J. B. Bachet, V. Kunzmann, F. Kreth, A. Block, M. Venerito, H. Oettle, M. Karthaus, J. Trojan, G. Folprecht, M. Lerch, F. Kullmann, M. Reiser, V. Heinemann, M. -A. Worns, H. Schulz, B. Garlipp, T. Yau, L. S. Chan, B. Juhasz, L. Landherr, T. Pinter, G. Bodoky, Z. Kahan, R. Mcdermott, D. Power, Leonardo Gianni, S. Siena, M. Milella, A. Falcone, R. Berardi, C. Bagala, F. Di Costanzo, F. Roila, A. Ardizzoni, Emanuela Maiello, S. Fanello, J. Wilmink, J. Willem De Groot, G. Creemers, E. Barroso, T. Rodrigues, C. Sarmento, C. E. Chee, D. Tai, T. M. Mercade, M. H. Medina, A. C. Mena, J. M. Santasusana, M. J. Flor Oncala, C. G. Martin, R. Lopez, A. Munoz, R. V. Garcia, I. Ales, B. L. Saez, F. Rivera, J. Sastre, C. -C. Wu, Y. -W. Tien, D. -C. Chan, T. -L. Hwang, J. Evans, J. Wadsley, P. Corrie, A. Biankin, A. Ko, D. Cardin, E. Chiorean, J. Bendell, A. Noonan, H. Kindler, N. Fernando, M. Beg, T. George, M. Noel, N. Loconte, F. Arena, J. Posey, R. Malhotra, C. Lopez, D. Sohal, R. Mcwilliams, W. Brenner, M. Womack, R. Seth, R. Lyer, N. Bahary, R. Marsh, R. Ramirez, C. Chua, J. Reeves, G. Manji, A. El-Khoueiry, R. Weaver, V. Sahai, W. Messersmith, R. Dreicer, A. Zakari, A. Bullock, B. Musher, M. Borad, E. Kim, D. Bajor, T. Huyck, H. Hatoum, H. Xiong, B. Pasche, J. Lacy, O. Olowokure, A. Cohn, D. Richards, R. Martin, A. Paulson, P. Fanta, S. Krishnamurthi, P. Oberstein, J. Fuloria

Risultato della ricerca: Contributo in rivista › Articolo in rivista

Abstract

PURPOSE This randomized, open-label trial compared the efficacy and safety of adjuvant nab-paclitaxel + gemcitabine with those of gemcitabine for resected pancreatic ductal adenocarcinoma (ClinicalTrials.gov identifier: NCT01964430).METHODSWe assigned 866 treatment-naive patients with pancreatic ductal adenocarcinoma to nab-paclitaxel (125 mg/m2) + gemcitabine (1,000 mg/m2) or gemcitabine alone to one 30-40 infusion on days 1, 8, and 15 of six 28-day cycles. The primary end point was independently assessed disease-free survival (DFS). Additional end points included investigator-assessed DFS, overall survival (OS), and safety.RESULTSTwo hundred eighty-seven of 432 patients and 310 of 434 patients completed nab-paclitaxel + gemcitabine and gemcitabine treatment, respectively. At primary data cutoff (December 31, 2018; median follow-up, 38.5 [interquartile range [IQR], 33.8-43 months), the median independently assessed DFS was 19.4 (nab-paclitaxel + gemcitabine) versus 18.8 months (gemcitabine; hazard ratio [HR], 0.88; 95% CI, 0.729 to 1.063; P =.18). The median investigator-assessed DFS was 16.6 (IQR, 8.4-47.0) and 13.7 (IQR, 8.3-44.1) months, respectively (HR, 0.82; 95% CI, 0.694 to 0.965; P =.02). The median OS (427 events; 68% mature) was 40.5 (IQR, 20.7 to not reached) and 36.2 (IQR, 17.7-53.3) months, respectively (HR, 0.82; 95% CI, 0.680 to 0.996; P =.045). At a 16-month follow-up (cutoff, April 3, 2020; median follow-up, 51.4 months [IQR, 47.0-57.0]), the median OS (511 events; 81% mature) was 41.8 (nab-paclitaxel + gemcitabine) versus 37.7 months (gemcitabine; HR, 0.82; 95% CI, 0.687 to 0.973; P =.0232). At the 5-year follow-up (cutoff, April 9, 2021; median follow-up, 63.2 months [IQR, 60.1-68.7]), the median OS (555 events; 88% mature) was 41.8 versus 37.7 months, respectively (HR, 0.80; 95% CI, 0.678 to 0.947; P =.0091). Eighty-six percent (nab-paclitaxel + gemcitabine) and 68% (gemcitabine) of patients experienced grade ≥ 3 treatment-emergent adverse events. Two patients per study arm died of treatment-emergent adverse events.CONCLUSIONThe primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine.

Lingua originale	English
pagine (da-a)	2007-2019
Numero di pagine	13
Rivista	Journal of Clinical Oncology
Volume	41
DOI	https://doi.org/10.1200/JCO.22.01134
Stato di pubblicazione	Pubblicato - 2023

Keywords

n/a

Accesso al documento

10.1200/JCO.22.01134

Altri file e collegamenti

Link a IRIS PubliCatt

Cita questo

Tempero, M. A., Pelzer, U., O'Reilly, E. M., Winter, J., Oh, D. .-Y., Li, C. .-P., Tortora, G., Chang, H. .-M., Lopez, C. D., Bekaii-Saab, T., Ko, A. H., Santoro, A., Park, J. O., Noel, M. S., Frassineti, G. L., Shan, Y. .-S., Dean, A., Riess, H., Van Cutsem, E., ... Fuloria, J. (2023). Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results from a Randomized, Open-Label, Phase III Trial. Journal of Clinical Oncology, 41, 2007-2019. https://doi.org/10.1200/JCO.22.01134

@article{29641cc47d644c68a10c3757410d2cec,

title = "Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results from a Randomized, Open-Label, Phase III Trial",

abstract = "PURPOSE This randomized, open-label trial compared the efficacy and safety of adjuvant nab-paclitaxel + gemcitabine with those of gemcitabine for resected pancreatic ductal adenocarcinoma (ClinicalTrials.gov identifier: NCT01964430).METHODSWe assigned 866 treatment-naive patients with pancreatic ductal adenocarcinoma to nab-paclitaxel (125 mg/m2) + gemcitabine (1,000 mg/m2) or gemcitabine alone to one 30-40 infusion on days 1, 8, and 15 of six 28-day cycles. The primary end point was independently assessed disease-free survival (DFS). Additional end points included investigator-assessed DFS, overall survival (OS), and safety.RESULTSTwo hundred eighty-seven of 432 patients and 310 of 434 patients completed nab-paclitaxel + gemcitabine and gemcitabine treatment, respectively. At primary data cutoff (December 31, 2018; median follow-up, 38.5 [interquartile range [IQR], 33.8-43 months), the median independently assessed DFS was 19.4 (nab-paclitaxel + gemcitabine) versus 18.8 months (gemcitabine; hazard ratio [HR], 0.88; 95% CI, 0.729 to 1.063; P =.18). The median investigator-assessed DFS was 16.6 (IQR, 8.4-47.0) and 13.7 (IQR, 8.3-44.1) months, respectively (HR, 0.82; 95% CI, 0.694 to 0.965; P =.02). The median OS (427 events; 68% mature) was 40.5 (IQR, 20.7 to not reached) and 36.2 (IQR, 17.7-53.3) months, respectively (HR, 0.82; 95% CI, 0.680 to 0.996; P =.045). At a 16-month follow-up (cutoff, April 3, 2020; median follow-up, 51.4 months [IQR, 47.0-57.0]), the median OS (511 events; 81% mature) was 41.8 (nab-paclitaxel + gemcitabine) versus 37.7 months (gemcitabine; HR, 0.82; 95% CI, 0.687 to 0.973; P =.0232). At the 5-year follow-up (cutoff, April 9, 2021; median follow-up, 63.2 months [IQR, 60.1-68.7]), the median OS (555 events; 88% mature) was 41.8 versus 37.7 months, respectively (HR, 0.80; 95% CI, 0.678 to 0.947; P =.0091). Eighty-six percent (nab-paclitaxel + gemcitabine) and 68% (gemcitabine) of patients experienced grade ≥ 3 treatment-emergent adverse events. Two patients per study arm died of treatment-emergent adverse events.CONCLUSIONThe primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine.",

keywords = "n/a, n/a",

author = "Tempero, {M. A.} and U. Pelzer and O'Reilly, {E. M.} and J. Winter and Oh, {D. -Y.} and Li, {C. -P.} and Giampaolo Tortora and Chang, {H. -M.} and Lopez, {C. D.} and T. Bekaii-Saab and Ko, {A. H.} and A. Santoro and Park, {J. O.} and Noel, {M. S.} and Frassineti, {G. L.} and Shan, {Y. -S.} and A. Dean and H. Riess and {Van Cutsem}, E. and J. Berlin and P. Philip and M. Moore and D. Goldstein and J. Tabernero and M. Li and S. Ferrara and {Le Bruchec}, Y. and G. Zhang and B. Lu and Biankin, {A. V.} and M. Reni and R. Epstein and P. Vasey and J. Shapiro and M. Burge and Chua, {Y. J.} and M. Harris and N. Pavlakis and N. Tebbutt and G. Prager and C. Dittrich and F. Langle and K. Philipp-Abbrederis and R. Greil and H. Stoger and M. Girschikofsky and T. Kuehr and {Van Laethem}, {J. -L.} and S. Laurent and N. Dhani and Ko, {Y. J.} and S. Dowden and P. Kavan and Tehfe, {M. E.} and E. Kubala and M. Kohoutek and P. Pfeiffer and M. Yilmaz and V. Parner and T. Salminen and Soveri, {L. -M.} and E. Korkeila and P. Osterlund and J. Taieb and D. Tougeron and P. Artru and Caroli-Bosc, {F. X.} and R. Guimbaud and A. Turpin and T. Walter and Bachet, {J. B.} and V. Kunzmann and F. Kreth and A. Block and M. Venerito and H. Oettle and M. Karthaus and J. Trojan and G. Folprecht and M. Lerch and F. Kullmann and M. Reiser and V. Heinemann and Worns, {M. -A.} and H. Schulz and B. Garlipp and T. Yau and Chan, {L. S.} and B. Juhasz and L. Landherr and T. Pinter and G. Bodoky and Z. Kahan and R. Mcdermott and D. Power and Leonardo Gianni and S. Siena and M. Milella and A. Falcone and R. Berardi and C. Bagala and {Di Costanzo}, F. and F. Roila and A. Ardizzoni and Emanuela Maiello and S. Fanello and J. Wilmink and {Willem De Groot}, J. and G. Creemers and E. Barroso and T. Rodrigues and C. Sarmento and Chee, {C. E.} and D. Tai and Mercade, {T. M.} and Medina, {M. H.} and Mena, {A. C.} and Santasusana, {J. M.} and {Flor Oncala}, {M. J.} and Martin, {C. G.} and R. Lopez and A. Munoz and Garcia, {R. V.} and I. Ales and Saez, {B. L.} and F. Rivera and J. Sastre and Wu, {C. -C.} and Tien, {Y. -W.} and Chan, {D. -C.} and Hwang, {T. -L.} and J. Evans and J. Wadsley and P. Corrie and A. Biankin and A. Ko and D. Cardin and E. Chiorean and J. Bendell and A. Noonan and H. Kindler and N. Fernando and M. Beg and T. George and M. Noel and N. Loconte and F. Arena and J. Posey and R. Malhotra and C. Lopez and D. Sohal and R. Mcwilliams and W. Brenner and M. Womack and R. Seth and R. Lyer and N. Bahary and R. Marsh and R. Ramirez and C. Chua and J. Reeves and G. Manji and A. El-Khoueiry and R. Weaver and V. Sahai and W. Messersmith and R. Dreicer and A. Zakari and A. Bullock and B. Musher and M. Borad and E. Kim and D. Bajor and T. Huyck and H. Hatoum and H. Xiong and B. Pasche and J. Lacy and O. Olowokure and A. Cohn and D. Richards and R. Martin and A. Paulson and P. Fanta and S. Krishnamurthi and P. Oberstein and J. Fuloria",

year = "2023",

doi = "10.1200/JCO.22.01134",

language = "English",

volume = "41",

pages = "2007--2019",

journal = "Journal of Clinical Oncology",

issn = "0732-183X",

publisher = "Lippincott Williams and Wilkins",

}

Tempero, MA, Pelzer, U, O'Reilly, EM, Winter, J, Oh, D-Y, Li, C-P, Tortora, G, Chang, H-M, Lopez, CD, Bekaii-Saab, T, Ko, AH, Santoro, A, Park, JO, Noel, MS, Frassineti, GL, Shan, Y-S, Dean, A, Riess, H, Van Cutsem, E, Berlin, J, Philip, P, Moore, M, Goldstein, D, Tabernero, J, Li, M, Ferrara, S, Le Bruchec, Y, Zhang, G, Lu, B, Biankin, AV, Reni, M, Epstein, R, Vasey, P, Shapiro, J, Burge, M, Chua, YJ, Harris, M, Pavlakis, N, Tebbutt, N, Prager, G, Dittrich, C, Langle, F, Philipp-Abbrederis, K, Greil, R, Stoger, H, Girschikofsky, M, Kuehr, T, Van Laethem, J-L, Laurent, S, Dhani, N, Ko, YJ, Dowden, S, Kavan, P, Tehfe, ME, Kubala, E, Kohoutek, M, Pfeiffer, P, Yilmaz, M, Parner, V, Salminen, T, Soveri, L-M, Korkeila, E, Osterlund, P, Taieb, J, Tougeron, D, Artru, P, Caroli-Bosc, FX, Guimbaud, R, Turpin, A, Walter, T, Bachet, JB, Kunzmann, V, Kreth, F, Block, A, Venerito, M, Oettle, H, Karthaus, M, Trojan, J, Folprecht, G, Lerch, M, Kullmann, F, Reiser, M, Heinemann, V, Worns, M-A, Schulz, H, Garlipp, B, Yau, T, Chan, LS, Juhasz, B, Landherr, L, Pinter, T, Bodoky, G, Kahan, Z, Mcdermott, R, Power, D, Gianni, L, Siena, S, Milella, M, Falcone, A, Berardi, R, Bagala, C, Di Costanzo, F, Roila, F, Ardizzoni, A, Maiello, E, Fanello, S, Wilmink, J, Willem De Groot, J, Creemers, G, Barroso, E, Rodrigues, T, Sarmento, C, Chee, CE, Tai, D, Mercade, TM, Medina, MH, Mena, AC, Santasusana, JM, Flor Oncala, MJ, Martin, CG, Lopez, R, Munoz, A, Garcia, RV, Ales, I, Saez, BL, Rivera, F, Sastre, J, Wu, C-C, Tien, Y-W, Chan, D-C, Hwang, T-L, Evans, J, Wadsley, J, Corrie, P, Biankin, A, Ko, A, Cardin, D, Chiorean, E, Bendell, J, Noonan, A, Kindler, H, Fernando, N, Beg, M, George, T, Noel, M, Loconte, N, Arena, F, Posey, J, Malhotra, R, Lopez, C, Sohal, D, Mcwilliams, R, Brenner, W, Womack, M, Seth, R, Lyer, R, Bahary, N, Marsh, R, Ramirez, R, Chua, C, Reeves, J, Manji, G, El-Khoueiry, A, Weaver, R, Sahai, V, Messersmith, W, Dreicer, R, Zakari, A, Bullock, A, Musher, B, Borad, M, Kim, E, Bajor, D, Huyck, T, Hatoum, H, Xiong, H, Pasche, B, Lacy, J, Olowokure, O, Cohn, A, Richards, D, Martin, R, Paulson, A, Fanta, P, Krishnamurthi, S, Oberstein, P & Fuloria, J 2023, 'Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results from a Randomized, Open-Label, Phase III Trial', Journal of Clinical Oncology, vol. 41, pagg. 2007-2019. https://doi.org/10.1200/JCO.22.01134

TY - JOUR

T1 - Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results from a Randomized, Open-Label, Phase III Trial

AU - Tempero, M. A.

AU - Pelzer, U.

AU - O'Reilly, E. M.

AU - Winter, J.

AU - Oh, D. -Y.

AU - Li, C. -P.

AU - Tortora, Giampaolo

AU - Chang, H. -M.

AU - Lopez, C. D.

AU - Bekaii-Saab, T.

AU - Ko, A. H.

AU - Santoro, A.

AU - Park, J. O.

AU - Noel, M. S.

AU - Frassineti, G. L.

AU - Shan, Y. -S.

AU - Dean, A.

AU - Riess, H.

AU - Van Cutsem, E.

AU - Berlin, J.

AU - Philip, P.

AU - Moore, M.

AU - Goldstein, D.

AU - Tabernero, J.

AU - Li, M.

AU - Ferrara, S.

AU - Le Bruchec, Y.

AU - Zhang, G.

AU - Lu, B.

AU - Biankin, A. V.

AU - Reni, M.

AU - Epstein, R.

AU - Vasey, P.

AU - Shapiro, J.

AU - Burge, M.

AU - Chua, Y. J.

AU - Harris, M.

AU - Pavlakis, N.

AU - Tebbutt, N.

AU - Prager, G.

AU - Dittrich, C.

AU - Langle, F.

AU - Philipp-Abbrederis, K.

AU - Greil, R.

AU - Stoger, H.

AU - Girschikofsky, M.

AU - Kuehr, T.

AU - Van Laethem, J. -L.

AU - Laurent, S.

AU - Dhani, N.

AU - Ko, Y. J.

AU - Dowden, S.

AU - Kavan, P.

AU - Tehfe, M. E.

AU - Kubala, E.

AU - Kohoutek, M.

AU - Pfeiffer, P.

AU - Yilmaz, M.

AU - Parner, V.

AU - Salminen, T.

AU - Soveri, L. -M.

AU - Korkeila, E.

AU - Osterlund, P.

AU - Taieb, J.

AU - Tougeron, D.

AU - Artru, P.

AU - Caroli-Bosc, F. X.

AU - Guimbaud, R.

AU - Turpin, A.

AU - Walter, T.

AU - Bachet, J. B.

AU - Kunzmann, V.

AU - Kreth, F.

AU - Block, A.

AU - Venerito, M.

AU - Oettle, H.

AU - Karthaus, M.

AU - Trojan, J.

AU - Folprecht, G.

AU - Lerch, M.

AU - Kullmann, F.

AU - Reiser, M.

AU - Heinemann, V.

AU - Worns, M. -A.

AU - Schulz, H.

AU - Garlipp, B.

AU - Yau, T.

AU - Chan, L. S.

AU - Juhasz, B.

AU - Landherr, L.

AU - Pinter, T.

AU - Bodoky, G.

AU - Kahan, Z.

AU - Mcdermott, R.

AU - Power, D.

AU - Gianni, Leonardo

AU - Siena, S.

AU - Milella, M.

AU - Falcone, A.

AU - Berardi, R.

AU - Bagala, C.

AU - Di Costanzo, F.

AU - Roila, F.

AU - Ardizzoni, A.

AU - Maiello, Emanuela

AU - Fanello, S.

AU - Wilmink, J.

AU - Willem De Groot, J.

AU - Creemers, G.

AU - Barroso, E.

AU - Rodrigues, T.

AU - Sarmento, C.

AU - Chee, C. E.

AU - Tai, D.

AU - Mercade, T. M.

AU - Medina, M. H.

AU - Mena, A. C.

AU - Santasusana, J. M.

AU - Flor Oncala, M. J.

AU - Martin, C. G.

AU - Lopez, R.

AU - Munoz, A.

AU - Garcia, R. V.

AU - Ales, I.

AU - Saez, B. L.

AU - Rivera, F.

AU - Sastre, J.

AU - Wu, C. -C.

AU - Tien, Y. -W.

AU - Chan, D. -C.

AU - Hwang, T. -L.

AU - Evans, J.

AU - Wadsley, J.

AU - Corrie, P.

AU - Biankin, A.

AU - Ko, A.

AU - Cardin, D.

AU - Chiorean, E.

AU - Bendell, J.

AU - Noonan, A.

AU - Kindler, H.

AU - Fernando, N.

AU - Beg, M.

AU - George, T.

AU - Noel, M.

AU - Loconte, N.

AU - Arena, F.

AU - Posey, J.

AU - Malhotra, R.

AU - Lopez, C.

AU - Sohal, D.

AU - Mcwilliams, R.

AU - Brenner, W.

AU - Womack, M.

AU - Seth, R.

AU - Lyer, R.

AU - Bahary, N.

AU - Marsh, R.

AU - Ramirez, R.

AU - Chua, C.

AU - Reeves, J.

AU - Manji, G.

AU - El-Khoueiry, A.

AU - Weaver, R.

AU - Sahai, V.

AU - Messersmith, W.

AU - Dreicer, R.

AU - Zakari, A.

AU - Bullock, A.

AU - Musher, B.

AU - Borad, M.

AU - Kim, E.

AU - Bajor, D.

AU - Huyck, T.

AU - Hatoum, H.

AU - Xiong, H.

AU - Pasche, B.

AU - Lacy, J.

AU - Olowokure, O.

AU - Cohn, A.

AU - Richards, D.

AU - Martin, R.

AU - Paulson, A.

AU - Fanta, P.

AU - Krishnamurthi, S.

AU - Oberstein, P.

AU - Fuloria, J.

PY - 2023

Y1 - 2023

N2 - PURPOSE This randomized, open-label trial compared the efficacy and safety of adjuvant nab-paclitaxel + gemcitabine with those of gemcitabine for resected pancreatic ductal adenocarcinoma (ClinicalTrials.gov identifier: NCT01964430).METHODSWe assigned 866 treatment-naive patients with pancreatic ductal adenocarcinoma to nab-paclitaxel (125 mg/m2) + gemcitabine (1,000 mg/m2) or gemcitabine alone to one 30-40 infusion on days 1, 8, and 15 of six 28-day cycles. The primary end point was independently assessed disease-free survival (DFS). Additional end points included investigator-assessed DFS, overall survival (OS), and safety.RESULTSTwo hundred eighty-seven of 432 patients and 310 of 434 patients completed nab-paclitaxel + gemcitabine and gemcitabine treatment, respectively. At primary data cutoff (December 31, 2018; median follow-up, 38.5 [interquartile range [IQR], 33.8-43 months), the median independently assessed DFS was 19.4 (nab-paclitaxel + gemcitabine) versus 18.8 months (gemcitabine; hazard ratio [HR], 0.88; 95% CI, 0.729 to 1.063; P =.18). The median investigator-assessed DFS was 16.6 (IQR, 8.4-47.0) and 13.7 (IQR, 8.3-44.1) months, respectively (HR, 0.82; 95% CI, 0.694 to 0.965; P =.02). The median OS (427 events; 68% mature) was 40.5 (IQR, 20.7 to not reached) and 36.2 (IQR, 17.7-53.3) months, respectively (HR, 0.82; 95% CI, 0.680 to 0.996; P =.045). At a 16-month follow-up (cutoff, April 3, 2020; median follow-up, 51.4 months [IQR, 47.0-57.0]), the median OS (511 events; 81% mature) was 41.8 (nab-paclitaxel + gemcitabine) versus 37.7 months (gemcitabine; HR, 0.82; 95% CI, 0.687 to 0.973; P =.0232). At the 5-year follow-up (cutoff, April 9, 2021; median follow-up, 63.2 months [IQR, 60.1-68.7]), the median OS (555 events; 88% mature) was 41.8 versus 37.7 months, respectively (HR, 0.80; 95% CI, 0.678 to 0.947; P =.0091). Eighty-six percent (nab-paclitaxel + gemcitabine) and 68% (gemcitabine) of patients experienced grade ≥ 3 treatment-emergent adverse events. Two patients per study arm died of treatment-emergent adverse events.CONCLUSIONThe primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine.

AB - PURPOSE This randomized, open-label trial compared the efficacy and safety of adjuvant nab-paclitaxel + gemcitabine with those of gemcitabine for resected pancreatic ductal adenocarcinoma (ClinicalTrials.gov identifier: NCT01964430).METHODSWe assigned 866 treatment-naive patients with pancreatic ductal adenocarcinoma to nab-paclitaxel (125 mg/m2) + gemcitabine (1,000 mg/m2) or gemcitabine alone to one 30-40 infusion on days 1, 8, and 15 of six 28-day cycles. The primary end point was independently assessed disease-free survival (DFS). Additional end points included investigator-assessed DFS, overall survival (OS), and safety.RESULTSTwo hundred eighty-seven of 432 patients and 310 of 434 patients completed nab-paclitaxel + gemcitabine and gemcitabine treatment, respectively. At primary data cutoff (December 31, 2018; median follow-up, 38.5 [interquartile range [IQR], 33.8-43 months), the median independently assessed DFS was 19.4 (nab-paclitaxel + gemcitabine) versus 18.8 months (gemcitabine; hazard ratio [HR], 0.88; 95% CI, 0.729 to 1.063; P =.18). The median investigator-assessed DFS was 16.6 (IQR, 8.4-47.0) and 13.7 (IQR, 8.3-44.1) months, respectively (HR, 0.82; 95% CI, 0.694 to 0.965; P =.02). The median OS (427 events; 68% mature) was 40.5 (IQR, 20.7 to not reached) and 36.2 (IQR, 17.7-53.3) months, respectively (HR, 0.82; 95% CI, 0.680 to 0.996; P =.045). At a 16-month follow-up (cutoff, April 3, 2020; median follow-up, 51.4 months [IQR, 47.0-57.0]), the median OS (511 events; 81% mature) was 41.8 (nab-paclitaxel + gemcitabine) versus 37.7 months (gemcitabine; HR, 0.82; 95% CI, 0.687 to 0.973; P =.0232). At the 5-year follow-up (cutoff, April 9, 2021; median follow-up, 63.2 months [IQR, 60.1-68.7]), the median OS (555 events; 88% mature) was 41.8 versus 37.7 months, respectively (HR, 0.80; 95% CI, 0.678 to 0.947; P =.0091). Eighty-six percent (nab-paclitaxel + gemcitabine) and 68% (gemcitabine) of patients experienced grade ≥ 3 treatment-emergent adverse events. Two patients per study arm died of treatment-emergent adverse events.CONCLUSIONThe primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine.

KW - n/a

UR - http://hdl.handle.net/10807/304684

U2 - 10.1200/JCO.22.01134

DO - 10.1200/JCO.22.01134

M3 - Article

SN - 0732-183X

VL - 41

SP - 2007

EP - 2019

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

ER -

Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results from a Randomized, Open-Label, Phase III Trial

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