Journal Article
. 2009 Feb;27(8).
doi: 10.1200/JCO.2008.18.4028.

Docetaxel With Cyclophosphamide Is Associated With an Overall Survival Benefit Compared With Doxorubicin and Cyclophosphamide: 7-Year Follow-Up of US Oncology Research Trial 9735

Stephen Jones 1 Frankie Ann Holmes  Joyce O'Shaughnessy  Joanne L Blum  Svetislava J Vukelja  Kristi J McIntyre  John E Pippen  James H Bordelon  Robert L Kirby  John Sandbach  William J Hyman  Donald A Richards  Robert G Mennel  Kristi A Boehm  Wally G Meyer  Lina Asmar  Daniel Mackey  Stefan Riedel  Hyman Muss  Michael A Savin  
Affiliations
  • PMID: 19204201
  •     135 citations

Abstract

Purpose: We previously reported that four cycles of docetaxel/cyclophosphamide (TC) produced superior disease-free survival (DFS) compared with four cycles of doxorubicin/cyclophosphamide (AC) in early breast cancer. Older women are under-represented in adjuvant chemotherapy trials. In our trial 16% of patients were > or = 65 years. We now report 7-year results for DFS and overall survival (OS) as well as the impact of age, hormone receptor status, and HER2 status on outcome and toxicity.

Patients And Methods: Patients were randomly assigned to receive either four cycles of standard-dose AC (60/600 mg/m(2); n = 510), or TC (75/600 mg/m(2); n = 506), administered by intravenous infusion every 3 weeks.

Results: The median age in women younger than 65, was 50 years (range, 27 to 64) and for women > or = 65 was 69 years (range, 65 to 77). Baseline characteristics in the two age subgroups were generally well matched, except that older women tended to have more lymph node involvement. At a median of 7 years follow-up, the difference in DFS between TC and AC was significant (81% TC v 75% AC; P = .033; hazard ratio [HR], 0.74; 95% CI 0.56 to 0.98) as was OS (87% TC v 82% AC; P = .032; HR, 0.69; 95% CI, 0.50 to 0.97). TC was superior in older patients as well as younger patients. There was no interaction of hormone-receptor status or HER-2 status and treatment. Older women experienced more febrile neutropenia with TC and more anemia with AC.

Conclusion: With longer follow-up, four cycles of TC was superior to standard AC (DFS and OS) and was a tolerable regimen in both older and younger patients.

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Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial.
Hyman B Muss, Mei-Yin C Polley, +25 authors, Lisa Carey.
J Clin Oncol, 2019 Jul 25; 37(26). PMID: 31339827    Free PMC article.
Taxanes for adjuvant treatment of early breast cancer.
Melina L Willson, Lucinda Burke, +3 authors, Nicholas Wilcken.
Cochrane Database Syst Rev, 2019 Sep 03; 9. PMID: 31476253    Free PMC article.
Systematic Review.
Cost-utility analysis of 21-gene assay for node-positive early breast cancer.
L Masucci, S Torres, +5 authors, W Isaranuwatchai.
Curr Oncol, 2019 Nov 12; 26(5). PMID: 31708649    Free PMC article.
Ambulatory Toxicity Management (AToM) in patients receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer - a pragmatic cluster randomized trial protocol.
Monika K Krzyzanowska, Jim A Julian, +6 authors, Eva Grunfeld.
BMC Cancer, 2019 Sep 07; 19(1). PMID: 31488084    Free PMC article.
'The same old story': thoughts on authorized doses of anticancer drugs.
Fausto Meriggi, Alberto Zaniboni.
Ther Adv Med Oncol, 2020 Mar 05; 12. PMID: 32127926    Free PMC article.
Concordance Study Between IBM Watson for Oncology and Clinical Practice for Patients with Cancer in China.
Na Zhou, Chuan-Tao Zhang, +12 authors, Xiao-Chun Zhang.
Oncologist, 2018 Sep 06; 24(6). PMID: 30181315    Free PMC article.
Early neutropenia on day 8 treated with adjuvant Docetaxel-based chemotherapy in early breast cancer patients: Putative mechanisms within the neutrophil pool system.
Yoshihiko Furuya.
PLoS One, 2019 Apr 19; 14(4). PMID: 30998754    Free PMC article.
Patient factors and their impact on neutropenic events: a systematic review and meta-analysis.
Pinkie Chambers, Yogini Jani, +3 authors, Ian C K Wong.
Support Care Cancer, 2019 Apr 18; 27(7). PMID: 30993453    Free PMC article.
Systematic Review.
A randomized study comparing docetaxel/cyclophosphamide (TC), 5-fluorouracil/epirubicin/cyclophosphamide (FEC) followed by TC, and TC followed by FEC for patients with hormone receptor-positive HER2-negative primary breast cancer.
Hiroshi Ishiguro, Norikazu Masuda, +16 authors, Masakazu Toi.
Breast Cancer Res Treat, 2020 Mar 15; 180(3). PMID: 32170634    Free PMC article.
The Impact of Adding Taxanes to Anthracyclines on Women with Breast Cancer Receiving Adjuvant Chemotherapy.
Erina Hilaj, Alketa Ymeri, Kleva P Shpati.
Cureus, 2020 Apr 08; 12(2). PMID: 32257663    Free PMC article.
Modern-day cardio-oncology: a report from the 'Heart Failure and World Congress on Acute Heart Failure 2018'.
Markus S Anker, Alessia Lena, +12 authors, Heart Failure Association Cardio-Oncology Study Group of the European Society of Cardiology.
ESC Heart Fail, 2018 Dec 21; 5(6). PMID: 30570223    Free PMC article.
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Neoadjuvant exemestane or exemestane plus docetaxel and cyclophosphamide tailored by clinicopathological response to 12 weeks' exemestane exposure in patients with estrogen receptor-positive breast cancer: A multicenter, open-label, phase II study.
Nobuaki Sato, Norikazu Masuda, +9 authors, Masakazu Toi.
Cancer Med, 2019 Jul 31; 8(12). PMID: 31361400    Free PMC article.
Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study.
Sundaram Subramanian, Rammohan Prasanna, +5 authors, Imran Ahmad.
Breast Cancer (Dove Med Press), 2020 Jun 18; 12. PMID: 32547188    Free PMC article.
Simulation of Chemotherapy Effects in Older Breast Cancer Patients With High Recurrence Scores.
Young Chandler, Jinani C Jayasekera, +3 authors, Jeanne S Mandelblatt.
J Natl Cancer Inst, 2019 Oct 16; 112(6). PMID: 31612208    Free PMC article.
Case 22-2020: A 62-Year-Old Woman with Early Breast Cancer during the Covid-19 Pandemic.
Laura M Spring, Michelle C Specht, +6 authors, Beverly Moy.
N Engl J Med, 2020 Jul 02; 383(3). PMID: 32610007    Free PMC article.
Current State of the Art in the Adjuvant Systemic Treatment of Premenopausal Patients With Early Breast Cancer.
Francesca Parisi, Maria Grazia Razeti, +7 authors, Matteo Lambertini.
Clin Med Insights Oncol, 2020 Jul 11; 14. PMID: 32647477    Free PMC article.
Adjuvant chemotherapy for node negative, high Recurrence ScoreTM breast cancer: in defense of de-escalation.
Diana Lake, Andrew D Seidman.
NPJ Breast Cancer, 2019 Aug 21; 5. PMID: 31428677    Free PMC article.
Eflapegrastim, a Long-Acting Granulocyte-Colony Stimulating Factor for the Management of Chemotherapy-Induced Neutropenia: Results of a Phase III Trial.
Lee S Schwartzberg, Gajanan Bhat, +9 authors, Patrick Wayne Cobb.
Oncologist, 2020 Jun 02; 25(8). PMID: 32476162    Free PMC article.
A comparison of eflapegrastim to pegfilgrastim in the management of chemotherapy-induced neutropenia in patients with early-stage breast cancer undergoing cytotoxic chemotherapy (RECOVER): A Phase 3 study.
Patrick Wayne Cobb, Yong Wha Moon, +5 authors, Lee S Schwartzberg.
Cancer Med, 2020 Jul 21; 9(17). PMID: 32687266    Free PMC article.
Four cycles of docetaxel and cyclophosphamide as adjuvant chemotherapy in node negative breast cancer: A real-world study.
Atul Batra, Malek B Hannouf, Noura Alsafar, Sasha Lupichuk.
Breast, 2020 Aug 31; 54. PMID: 32861882    Free PMC article.
Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies.
Shani Paluch-Shimon, Nathan I Cherny, +4 authors, Fatima Cardoso.
ESMO Open, 2020 Sep 08; 5(5). PMID: 32893189    Free PMC article.
Clinical Validation of PITX2 DNA Methylation to Predict Outcome in High-Risk Breast Cancer Patients Treated with Anthracycline-Based Chemotherapy.
Manfred Schmitt, Olaf G Wilhelm, +11 authors, Marion Kiechle.
Breast Care (Basel), 2019 Feb 26; 13(6). PMID: 30800037    Free PMC article.
De-escalation yes, but not at the expense of efficacy: in defense of better treatment.
Charles L Shapiro.
NPJ Breast Cancer, 2019 Aug 21; 5. PMID: 31428678    Free PMC article.
Beyond Chemotherapies: Recent Strategies in Breast Cancer Treatment.
Arthur Foulon, Pierrick Theret, Lise Rodat-Despoix, Philippe Kischel.
Cancers (Basel), 2020 Sep 20; 12(9). PMID: 32947780    Free PMC article.
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Interdisciplinary Screening, Diagnosis, Therapy and Follow-up of Breast Cancer. Guideline of the DGGG and the DKG (S3-Level, AWMF Registry Number 032/045OL, December 2017) - Part 2 with Recommendations for the Therapy of Primary, Recurrent and Advanced Breast Cancer.
Achim Wöckel, Jasmin Festl, +94 authors, Stephanie Stangl.
Geburtshilfe Frauenheilkd, 2018 Dec 26; 78(11). PMID: 30581198    Free PMC article.
Taxane & cyclophosphamide vs anthracycline & taxane-based chemotherapy as adjuvant treatment for breast cancer: a pooled analysis of randomized controlled trials by the Hellenic Academy of Oncology.
Panagiotis Ntellas, Nikolaos Spathas, +2 authors, Emmanouil Saloustros.
Oncotarget, 2019 Mar 07; 10(11). PMID: 30838092    Free PMC article.
The impact of age on the risk of ipsilateral breast tumor recurrence after breast-conserving therapy in breast cancer patients with a > 5 mm margin treated without boost irradiation.
Yuka Ono, Michio Yoshimura, +6 authors, Takashi Mizowaki.
Radiat Oncol, 2019 Jul 12; 14(1). PMID: 31291997    Free PMC article.
Antitumor activity and efficacy of shorter versus longer duration of anthracycline-taxane neoadjuvant chemotherapy in stage II-III HER2-negative breast cancer: a 10-year, retrospective analysis.
Riccardo Lobefaro, Emma Zattarin, +15 authors, Giuseppe Capri.
Ther Adv Med Oncol, 2020 Dec 19; 12. PMID: 33335565    Free PMC article.
Feasibility of using a pragmatic trials model to compare two primary febrile neutropenia prophylaxis regimens (ciprofloxacin versus G-CSF) in patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer (REaCT-TC).
Mark Clemons, Sasha Mazzarello, +12 authors, Dean Fergusson.
Support Care Cancer, 2018 Aug 14; 27(4). PMID: 30099602
Standard Anthracycline Based Versus Docetaxel-Capecitabine in Early High Clinical and/or Genomic Risk Breast Cancer in the EORTC 10041/BIG 3-04 MINDACT Phase III Trial.
Suzette Delaloge, Martine Piccart, +27 authors, MINDACT investigators and the TRANSBIG Consortium.
J Clin Oncol, 2020 Feb 23; 38(11). PMID: 32083990    Free PMC article.
Clinical utilization of long-acting granulocyte colony-stimulating factor (pegfilgrastim) prophylaxis in breast cancer patients with adjuvant docetaxel-cyclophosphamide chemotherapy.
Ye Won Jeon, Seung Taek Lim, +4 authors, Young Jin Suh.
Ann Surg Treat Res, 2021 Feb 16; 100(2). PMID: 33585350    Free PMC article.
Update on systemic treatment in early triple negative breast cancer.
Martín Núñez Abad, Silvia Calabuig-Fariñas, +6 authors, Carlos Camps Herrero.
Ther Adv Med Oncol, 2021 Feb 23; 13. PMID: 33613695    Free PMC article.
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Machine Learning for Detection of Safety Signals From Spontaneous Reporting System Data: Example of Nivolumab and Docetaxel.
Ji-Hwan Bae, Yeon-Hee Baek, +3 authors, Ju-Young Shin.
Front Pharmacol, 2021 Feb 26; 11. PMID: 33628176    Free PMC article.
Activity of docetaxel, carboplatin, and doxorubicin in patient-derived triple-negative breast cancer xenografts.
Miguel Martin, Rocio Ramos-Medina, +20 authors, Sara Lopez-Tarruella.
Sci Rep, 2021 Mar 31; 11(1). PMID: 33782404    Free PMC article.