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Tumour shrinkage at 6 weeks predicts favorable clinical outcomes in a phase III study of gemcitabine and oxaliplatin with or without erlotinib for advanced biliary tract cancer.

Kim ST, Jang KT, Lee SJ, Jang HL, Lee J, Park SH, Park YS, Lim HY, Kang WK, Park JO - BMC Cancer (2015)

Bottom Line: ETS was significantly correlated with the overall RR (correlation coefficient, 0.53; p < 0.01).The median PFS and OS did not differ according to erlotinib administration.However, the median PFS (7.3 vs. 2.1 months, p < 0.01) and OS (10.7 vs. 5.8 months, p < 0.01) were significantly longer amongst patients with ETS at 6 weeks after treatment, irrespective of erlotinib administration.

View Article: PubMed Central - PubMed

Affiliation: Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-Ro Gangnam-gu, Seoul, 135-710, South Korea. seungtae1.kim@samsung.com.

ABSTRACT

Background: The aim of this study was to determine whether early tumor shrinkage (ETS) at 6 weeks after treatment correlates with progression-free survival (PFS) and overall survival (OS) in advanced biliary tract cancer (BTC) patients receiving gemcitabine plus oxaliplatin (GEMOX), with or without erlotinib.

Methods: This was a multicenter, open label, randomized, phase III trial of 103 BTC patients (ClinicalTrials.gov Identifier; NCT01149122, and Rigistration date; January, 7, 2010), comparing GEMOX with GEMOX plus erlotinib. Tumor shrinkage was expressed as a relative decrease compared to baseline and was dichotomized according to a previously reported cutoff value of 10 %.

Results: Fifty-four patients (52.4 %) received GEMOX and 49 patients (47.6 %) received GEMOX plus erlotinib. The latter achieved a better overall response rate (RR) (40.8 % vs. 18.6 %, p = 0.02) and showed ETS more frequently (63.2 % vs. 40.7 %, p = 0.03). ETS was significantly correlated with the overall RR (correlation coefficient, 0.53; p < 0.01). The median PFS and OS did not differ according to erlotinib administration. However, the median PFS (7.3 vs. 2.1 months, p < 0.01) and OS (10.7 vs. 5.8 months, p < 0.01) were significantly longer amongst patients with ETS at 6 weeks after treatment, irrespective of erlotinib administration. In patients with wild-type KRAS who were treated with GEMOX plus erlotinib, ETS was a significant prognostic factor for PFS (p < 0.01).

Conclusions: ETS might predict PFS and OS in BTC patients treated with GEMOX with or without erlotinib. Additionally, ETS may be an indication for adding erlotinib to chemotherapy for BTC patients wild-type KRAS. These findings need to be prospectively validated.

No MeSH data available.


Related in: MedlinePlus

CONSORT flow diagram
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Fig1: CONSORT flow diagram

Mentions: The eligibility criteria and design of this study have been previously described [6]. Briefly, this was an open-label, randomized, phase III trial, in which 268 patients with advanced BTCs were randomly assigned to receive either erlotinib plus GEMOX (135 patients) or GEMOX alone (133 patients) as first-line treatment. All patients provided written informed consent according to institutional guidelines, and the study was approved by the Institutional Review Board. Tumor response was evaluated every 6 weeks using computed tomography (CT) and was assessed by the local investigators according to the Response Evaluation Criteria in Solid Tumors, version 1.0. A total of 103 patients were available for the evaluation of ETS 6 weeks after treatment as well as tumor KRAS mutation status (Fig. 1). Tumor shrinkage was expressed as a relative decrease compared to baseline and was categorized according to a previously reported cutoff value (10 %) [8, 12].Fig. 1


Tumour shrinkage at 6 weeks predicts favorable clinical outcomes in a phase III study of gemcitabine and oxaliplatin with or without erlotinib for advanced biliary tract cancer.

Kim ST, Jang KT, Lee SJ, Jang HL, Lee J, Park SH, Park YS, Lim HY, Kang WK, Park JO - BMC Cancer (2015)

CONSORT flow diagram
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4507321&req=5

Fig1: CONSORT flow diagram
Mentions: The eligibility criteria and design of this study have been previously described [6]. Briefly, this was an open-label, randomized, phase III trial, in which 268 patients with advanced BTCs were randomly assigned to receive either erlotinib plus GEMOX (135 patients) or GEMOX alone (133 patients) as first-line treatment. All patients provided written informed consent according to institutional guidelines, and the study was approved by the Institutional Review Board. Tumor response was evaluated every 6 weeks using computed tomography (CT) and was assessed by the local investigators according to the Response Evaluation Criteria in Solid Tumors, version 1.0. A total of 103 patients were available for the evaluation of ETS 6 weeks after treatment as well as tumor KRAS mutation status (Fig. 1). Tumor shrinkage was expressed as a relative decrease compared to baseline and was categorized according to a previously reported cutoff value (10 %) [8, 12].Fig. 1

Bottom Line: ETS was significantly correlated with the overall RR (correlation coefficient, 0.53; p < 0.01).The median PFS and OS did not differ according to erlotinib administration.However, the median PFS (7.3 vs. 2.1 months, p < 0.01) and OS (10.7 vs. 5.8 months, p < 0.01) were significantly longer amongst patients with ETS at 6 weeks after treatment, irrespective of erlotinib administration.

View Article: PubMed Central - PubMed

Affiliation: Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-Ro Gangnam-gu, Seoul, 135-710, South Korea. seungtae1.kim@samsung.com.

ABSTRACT

Background: The aim of this study was to determine whether early tumor shrinkage (ETS) at 6 weeks after treatment correlates with progression-free survival (PFS) and overall survival (OS) in advanced biliary tract cancer (BTC) patients receiving gemcitabine plus oxaliplatin (GEMOX), with or without erlotinib.

Methods: This was a multicenter, open label, randomized, phase III trial of 103 BTC patients (ClinicalTrials.gov Identifier; NCT01149122, and Rigistration date; January, 7, 2010), comparing GEMOX with GEMOX plus erlotinib. Tumor shrinkage was expressed as a relative decrease compared to baseline and was dichotomized according to a previously reported cutoff value of 10 %.

Results: Fifty-four patients (52.4 %) received GEMOX and 49 patients (47.6 %) received GEMOX plus erlotinib. The latter achieved a better overall response rate (RR) (40.8 % vs. 18.6 %, p = 0.02) and showed ETS more frequently (63.2 % vs. 40.7 %, p = 0.03). ETS was significantly correlated with the overall RR (correlation coefficient, 0.53; p < 0.01). The median PFS and OS did not differ according to erlotinib administration. However, the median PFS (7.3 vs. 2.1 months, p < 0.01) and OS (10.7 vs. 5.8 months, p < 0.01) were significantly longer amongst patients with ETS at 6 weeks after treatment, irrespective of erlotinib administration. In patients with wild-type KRAS who were treated with GEMOX plus erlotinib, ETS was a significant prognostic factor for PFS (p < 0.01).

Conclusions: ETS might predict PFS and OS in BTC patients treated with GEMOX with or without erlotinib. Additionally, ETS may be an indication for adding erlotinib to chemotherapy for BTC patients wild-type KRAS. These findings need to be prospectively validated.

No MeSH data available.


Related in: MedlinePlus