Phase II gemcitabine and capecitabine combination therapy in recurrent or metastatic breast cancer patients pretreated with anthracycline and taxane

Ji Soo Park, Hei Cheul Jeung, SunYoung Rha, Joong Bae Ahn, Beodeul Kang, Hong Jae Chon, Min Hee Hong, Seungtaek Lim, Woo Ick Yang, Chung Mo Nam, Hyuncheol Chung

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Purpose: We conducted a phase II study evaluating safety and efficacy of combination gemcitabine and capecitabine therapy for metastatic breast cancer patients following anthracycline and taxane treatment in Korea. Methods: This was a single-arm, non-randomized phase II study. Patients received 1,000 mg/m2 gemcitabine intravenously over 30 min on days 1 and 8, and 1,250 mg/m2 capecitabine orally twice daily on days 1-14 until disease progression or intolerable toxicity occurred. This regimen was repeated every 3 weeks. The primary outcome assessed was overall response rate [ORR, complete response (CR) + partial response (PR) as the best response], and secondary outcomes were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) [maintenance of CR + PR + stable disease (SD) for at least 3 months], drug toxicity, and predictive factors for response to this regimen. Results: Of 41 patients, the ORR was 39.0 % (CR 0 %; PR 39.0 %), and DCR was 78.0 % using this chemotherapy. DCR for 6 and 12 months was 68.3 and 26.8 %, respectively. Median PFS was 10.0 months [95 % confidence interval (CI) 7.8-12.1], and median OS was 25.1 months (95 % CI 18.2-32.1). Prominent toxicities were neutropenia and hand-foot syndrome. Most adverse events were well known, relatively moderate, and reversible. Taxane sensitivity [odds ratio (OR) 0.169; 95 % CI 0.034-0.826; P = 0.028] and hepatic metastasis (OR 0.097; 95 % CI 0.017-0.559; P = 0.009) were significantly predictive of response to gemcitabine and capecitabine combination. Conclusions: This study showed reproducible anticancer activity and tolerable toxicity of gemcitabine and capecitabine combination therapy in recurrent or metastatic Korean breast cancer patients previously treated with anthracycline and taxane.

Original languageEnglish
Pages (from-to)799-808
Number of pages10
JournalCancer Chemotherapy and Pharmacology
Volume74
Issue number4
DOIs
Publication statusPublished - 2014 Aug 9

Fingerprint

gemcitabine
Anthracyclines
Disease control
Toxicity
Confidence Intervals
Breast Neoplasms
Disease-Free Survival
Odds Ratio
Hand-Foot Syndrome
Chemotherapy
Survival
Therapeutics
Korea
Neutropenia
Drug-Related Side Effects and Adverse Reactions
Disease Progression
Maintenance
Neoplasm Metastasis
Safety
Drug Therapy

All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

Cite this

Park, Ji Soo ; Jeung, Hei Cheul ; Rha, SunYoung ; Ahn, Joong Bae ; Kang, Beodeul ; Chon, Hong Jae ; Hong, Min Hee ; Lim, Seungtaek ; Yang, Woo Ick ; Nam, Chung Mo ; Chung, Hyuncheol. / Phase II gemcitabine and capecitabine combination therapy in recurrent or metastatic breast cancer patients pretreated with anthracycline and taxane. In: Cancer Chemotherapy and Pharmacology. 2014 ; Vol. 74, No. 4. pp. 799-808.
@article{a8203b6eb1d14ba6bb3e38a4adaa5401,
title = "Phase II gemcitabine and capecitabine combination therapy in recurrent or metastatic breast cancer patients pretreated with anthracycline and taxane",
abstract = "Purpose: We conducted a phase II study evaluating safety and efficacy of combination gemcitabine and capecitabine therapy for metastatic breast cancer patients following anthracycline and taxane treatment in Korea. Methods: This was a single-arm, non-randomized phase II study. Patients received 1,000 mg/m2 gemcitabine intravenously over 30 min on days 1 and 8, and 1,250 mg/m2 capecitabine orally twice daily on days 1-14 until disease progression or intolerable toxicity occurred. This regimen was repeated every 3 weeks. The primary outcome assessed was overall response rate [ORR, complete response (CR) + partial response (PR) as the best response], and secondary outcomes were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) [maintenance of CR + PR + stable disease (SD) for at least 3 months], drug toxicity, and predictive factors for response to this regimen. Results: Of 41 patients, the ORR was 39.0 {\%} (CR 0 {\%}; PR 39.0 {\%}), and DCR was 78.0 {\%} using this chemotherapy. DCR for 6 and 12 months was 68.3 and 26.8 {\%}, respectively. Median PFS was 10.0 months [95 {\%} confidence interval (CI) 7.8-12.1], and median OS was 25.1 months (95 {\%} CI 18.2-32.1). Prominent toxicities were neutropenia and hand-foot syndrome. Most adverse events were well known, relatively moderate, and reversible. Taxane sensitivity [odds ratio (OR) 0.169; 95 {\%} CI 0.034-0.826; P = 0.028] and hepatic metastasis (OR 0.097; 95 {\%} CI 0.017-0.559; P = 0.009) were significantly predictive of response to gemcitabine and capecitabine combination. Conclusions: This study showed reproducible anticancer activity and tolerable toxicity of gemcitabine and capecitabine combination therapy in recurrent or metastatic Korean breast cancer patients previously treated with anthracycline and taxane.",
author = "Park, {Ji Soo} and Jeung, {Hei Cheul} and SunYoung Rha and Ahn, {Joong Bae} and Beodeul Kang and Chon, {Hong Jae} and Hong, {Min Hee} and Seungtaek Lim and Yang, {Woo Ick} and Nam, {Chung Mo} and Hyuncheol Chung",
year = "2014",
month = "8",
day = "9",
doi = "10.1007/s00280-014-2551-4",
language = "English",
volume = "74",
pages = "799--808",
journal = "Cancer Chemotherapy and Pharmacology",
issn = "0344-5704",
publisher = "Springer Verlag",
number = "4",

}

Phase II gemcitabine and capecitabine combination therapy in recurrent or metastatic breast cancer patients pretreated with anthracycline and taxane. / Park, Ji Soo; Jeung, Hei Cheul; Rha, SunYoung; Ahn, Joong Bae; Kang, Beodeul; Chon, Hong Jae; Hong, Min Hee; Lim, Seungtaek; Yang, Woo Ick; Nam, Chung Mo; Chung, Hyuncheol.

In: Cancer Chemotherapy and Pharmacology, Vol. 74, No. 4, 09.08.2014, p. 799-808.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase II gemcitabine and capecitabine combination therapy in recurrent or metastatic breast cancer patients pretreated with anthracycline and taxane

AU - Park, Ji Soo

AU - Jeung, Hei Cheul

AU - Rha, SunYoung

AU - Ahn, Joong Bae

AU - Kang, Beodeul

AU - Chon, Hong Jae

AU - Hong, Min Hee

AU - Lim, Seungtaek

AU - Yang, Woo Ick

AU - Nam, Chung Mo

AU - Chung, Hyuncheol

PY - 2014/8/9

Y1 - 2014/8/9

N2 - Purpose: We conducted a phase II study evaluating safety and efficacy of combination gemcitabine and capecitabine therapy for metastatic breast cancer patients following anthracycline and taxane treatment in Korea. Methods: This was a single-arm, non-randomized phase II study. Patients received 1,000 mg/m2 gemcitabine intravenously over 30 min on days 1 and 8, and 1,250 mg/m2 capecitabine orally twice daily on days 1-14 until disease progression or intolerable toxicity occurred. This regimen was repeated every 3 weeks. The primary outcome assessed was overall response rate [ORR, complete response (CR) + partial response (PR) as the best response], and secondary outcomes were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) [maintenance of CR + PR + stable disease (SD) for at least 3 months], drug toxicity, and predictive factors for response to this regimen. Results: Of 41 patients, the ORR was 39.0 % (CR 0 %; PR 39.0 %), and DCR was 78.0 % using this chemotherapy. DCR for 6 and 12 months was 68.3 and 26.8 %, respectively. Median PFS was 10.0 months [95 % confidence interval (CI) 7.8-12.1], and median OS was 25.1 months (95 % CI 18.2-32.1). Prominent toxicities were neutropenia and hand-foot syndrome. Most adverse events were well known, relatively moderate, and reversible. Taxane sensitivity [odds ratio (OR) 0.169; 95 % CI 0.034-0.826; P = 0.028] and hepatic metastasis (OR 0.097; 95 % CI 0.017-0.559; P = 0.009) were significantly predictive of response to gemcitabine and capecitabine combination. Conclusions: This study showed reproducible anticancer activity and tolerable toxicity of gemcitabine and capecitabine combination therapy in recurrent or metastatic Korean breast cancer patients previously treated with anthracycline and taxane.

AB - Purpose: We conducted a phase II study evaluating safety and efficacy of combination gemcitabine and capecitabine therapy for metastatic breast cancer patients following anthracycline and taxane treatment in Korea. Methods: This was a single-arm, non-randomized phase II study. Patients received 1,000 mg/m2 gemcitabine intravenously over 30 min on days 1 and 8, and 1,250 mg/m2 capecitabine orally twice daily on days 1-14 until disease progression or intolerable toxicity occurred. This regimen was repeated every 3 weeks. The primary outcome assessed was overall response rate [ORR, complete response (CR) + partial response (PR) as the best response], and secondary outcomes were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) [maintenance of CR + PR + stable disease (SD) for at least 3 months], drug toxicity, and predictive factors for response to this regimen. Results: Of 41 patients, the ORR was 39.0 % (CR 0 %; PR 39.0 %), and DCR was 78.0 % using this chemotherapy. DCR for 6 and 12 months was 68.3 and 26.8 %, respectively. Median PFS was 10.0 months [95 % confidence interval (CI) 7.8-12.1], and median OS was 25.1 months (95 % CI 18.2-32.1). Prominent toxicities were neutropenia and hand-foot syndrome. Most adverse events were well known, relatively moderate, and reversible. Taxane sensitivity [odds ratio (OR) 0.169; 95 % CI 0.034-0.826; P = 0.028] and hepatic metastasis (OR 0.097; 95 % CI 0.017-0.559; P = 0.009) were significantly predictive of response to gemcitabine and capecitabine combination. Conclusions: This study showed reproducible anticancer activity and tolerable toxicity of gemcitabine and capecitabine combination therapy in recurrent or metastatic Korean breast cancer patients previously treated with anthracycline and taxane.

UR - http://www.scopus.com/inward/record.url?scp=84925545437&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84925545437&partnerID=8YFLogxK

U2 - 10.1007/s00280-014-2551-4

DO - 10.1007/s00280-014-2551-4

M3 - Article

C2 - 25107569

AN - SCOPUS:84925545437

VL - 74

SP - 799

EP - 808

JO - Cancer Chemotherapy and Pharmacology

JF - Cancer Chemotherapy and Pharmacology

SN - 0344-5704

IS - 4

ER -