Definitive Results of a Phase III Adjuvant Trial Comparing Three Chemotherapy Regimens in Women With Operable, Node-Positive Breast Cancer: The NSABP B-38 Trial

Swain, Sandra M.; Tang, Gong; Geyer, Charles E.; Rastogi, Priya; Atkins, James N.; Donnellan, Paul; Fehrenbacher, Louis; Azar, Catherine A.; Robidoux, André; Polikoff, Jonathan; Brufsky, Adam; Biggs, David D.; Levine, Edward A.; Zapas, John L.; Provencher, Louise; Northfelt, Donald W.; Paik, Soonmyung; Costantino, Joseph P.; Mamounas, Eleftherios P.; Wolmark, Norman

doi:10.1200/jco.2012.48.1275

Cited by 142 publications

(104 citation statements)

References 16 publications

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“…After 5 years, disease free and overall survival was not different in three arms. Febrile neutropenia and diarrhea were more frequent in TAC arm and neuropathy was more frequent in dose dense regimens [22].…”

Section: Discussionmentioning

confidence: 99%

The Efficacy and Safety of Gemcitabine Plus Paclitaxel Compared to Doxorubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Mohammadianpanah¹

2015

JCPCR

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Section: Discussionmentioning

confidence: 99%

The Efficacy and Safety of Gemcitabine Plus Paclitaxel Compared to Doxorubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Mohammadianpanah¹

2015

JCPCR

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“…In a recent published phase III NSABP (National Surgical Adjuvant Bowel Project) B-38 trial, 4.894 patients with node-positive breast cancer randomized to six cycles of docetaxel, doxorubicin, and cyclophosphamide (TAC) or four cycles of DD AC followed by four cycles of DD paclitaxel or DD AC with paclitaxel every 3 weeks with four cycles of gemcitabine added to the DD paclitaxel (Swain et al, 2013). In this trial adding gemcitabine to dose dense chemotherapy did not improve outcomes and no significant difference was reported between TAC and DD AC with paclitaxel regimens with different toxicity profile.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel versus Conventional Dose Doxorubicin, Cyclophosphamide Followed by Paclitaxel or Docetaxel in Patients with Node-Positive Breast Cancer

Yazılıtaş¹,

Şendur²,

Karaca³

et al. 2015

Asian Pacific Journal of Cancer Prevention

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Breast cancer is the most commonly diagnosed cancer type and is the second leading cause of death due to cancer among women all over the world and breast cancer alone is expected to account for 29% of all new cancers among women (Siegel et al., 2014). However, surgery is the only curative treatment modality of early breast cancer patients, adjuvant systemic chemotherapy following surgery have significant effect on disease free survival Afterunivariate and multivariate analysis were performed, 3-year DFS rates were 89%, 81%, and 75%, respectively (p=0.12) and three year OS rates were 96.6%, 89%, and 75% (p=0.62). Conclusions: In this study, no significant difference was found between adjuvant dose dense and conventional taxane treatment regimens.

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“…The results of three large trials, NSABP-B38 [25], NSABP-B40 [26] and Neo-tAnGo [29], investigating the role of gemcitabine in the adjuvant and neoadjuvant setting, showed no benefit from the addition of gemcitabine to anthracycline and taxane-based chemotherapy treatments for early breast cancer. Our toxicity data demonstrates an increase in grade 3 and 4 hematological toxicity, in dose reductions and postponement of treatment cycles, as well as an increased need for G-CSF and antibiotic support and a higher number of fatalities in the FEC-DG arm compared with FEC-Doc alone.…”

mentioning

confidence: 99%

“…It is possible that without these preventive measures, the side effects of adding gemcitabine would have been greater. For example, in the NSABP-B38 trial [25] adjuvant chemotherapy with doxorubicin and cyclophosphamide was followed by paclitaxel and gemcitabine. G-CSF support was used in 93 % of chemotherapy cycles resulting in low rates of neutropenia (3 %).…”

mentioning

confidence: 99%

Toxicity Assessment of a Phase III Study Evaluating FEC-Doc and FEC-Doc Combined with Gemcitabine as an Adjuvant Treatment for High-Risk Early Breast Cancer: the SUCCESS-A Trial

Schröder

Rack

Sommer

et al. 2016

Geburtshilfe Frauenheilkd

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!Introduction: This paper aims to evaluate the toxicity profile of additive gemcitabine to adjuvant taxane-based chemotherapy in breast cancer patients. Methods: Patients enrolled in this open-label randomized controlled Phase III study were treated with 3 cycles of epirubicin-fluorouracil-cyclophosphamide (FEC) chemotherapy followed by 3 cycles of docetaxel with those receiving 3 cycles of FEC followed by 3 cycles of gemcitabine-docetaxel (FEC-DG). 3690 patients were evaluated according to National Cancer Institute (NCI) toxicity criteria (CTCAE). The study medications were assessed by the occurrence of grade 3-4 adverse events, dose reductions, postponements of treatment cycles and granulocyte colony-stimulating factor (G-CSF) support. Results: No differences in neutropenia or febrile neutropenia were demonstrated. However, thrombocytopenia was significantly increased with FEC-DG treatment (2.0 vs. 0.5 %, p < 0.001), as was leukopenia (64.1 vs. 58.5 %, p < 0.001). With FEC-DG significantly more G-CSF support in cycles 4 to 6 (FEC-DG: 57.8 %, FEC-D: 36.3 %, p < 0.001) was provided. Transaminase elevation was significantly more common with FEC-DG (SGPT: 6.3 %, SGOT: 2%), whereas neuropathy (1.2 %), arthralgia (1.6 %) and bone pain (2.6 %) were more common using FEC-D. Dose reductions > 20 % (4 vs. 2.4 %) and postponement of treatment cycles (0.9 vs. 0.4 %) were significantly more frequent in the FEC-DG arm. Eight deaths occurred during treatment in the FEC-DG arm and four in the FEC-D arm. Conclusion: The addition of gemcitabine increased hematological toxicity and was associated with more dose reductions and postponements of treatment cycles.

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Definitive Results of a Phase III Adjuvant Trial Comparing Three Chemotherapy Regimens in Women With Operable, Node-Positive Breast Cancer: The NSABP B-38 Trial

Abstract: Adding G to DD AC→P did not improve outcomes. No significant differences in efficacy were identified between DD AC→P and TAC, although toxicity profiles differed.

Cited by 142 publications

References 16 publications

The Efficacy and Safety of Gemcitabine Plus Paclitaxel Compared to Doxorubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

The Efficacy and Safety of Gemcitabine Plus Paclitaxel Compared to Doxorubicin Plus Cyclophosphamide as Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Efficacy of Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel versus Conventional Dose Doxorubicin, Cyclophosphamide Followed by Paclitaxel or Docetaxel in Patients with Node-Positive Breast Cancer

Toxicity Assessment of a Phase III Study Evaluating FEC-Doc and FEC-Doc Combined with Gemcitabine as an Adjuvant Treatment for High-Risk Early Breast Cancer: the SUCCESS-A Trial

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