Comparison of efficacy of neoadjuvant chemotherapy FEC 100 and Docetaxel 75 versus AC and Docetaxel in locally advanced breast cancer: a randomized clinical study

Dhanraj, K Manoj; Dubashi, Biswajit; Gollapalli, Shanmukha Rao; Kayal, Smita; Cyriac, Sunu

doi:10.1007/s12032-015-0697-5

Cited by 5 publications

(7 citation statements)

References 19 publications

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“…There was no signi cant difference in the toxicities between our present study arms. In our current cohort, febrile neutropenia was within the 11-34% range reported in previous studies [9,19]. In terms of QoL outcomes, there was also no signi cant difference between our two study groups.…”

Section: Discussionsupporting

confidence: 72%

“…In the NSABP-B27 study, the pCR rate in the AC followed by taxane treatment group with ER positivity was 14.1%, comparable to the 17.3% rate found in our present series. In addition, our observed pCR rate was low compared to a prior Indian study with a similar design concept [19]. The difference in the pCR rate between our present study and the prior Indian report may also have been affected by differences in the proportion of triple negative breast cancers (TNBCs) and HER2-positive tumors, even though they had a similar clinical stage (neo-shorter vs. India, 29.8% vs. 49%).…”

Section: Discussioncontrasting

confidence: 72%

“…In addition, there is a reported QoL decrease due to increased exposure to anthracycline and taxane in the AC4-D4 regimen. Strategies to reduce the number of chemotherapy cycles has also been explored in another study [19].…”

Section: Discussionmentioning

confidence: 99%

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Randomized phase III trial of a neoadjuvant regimen of four cycles of adriamycin plus cyclophosphamide followed by four cycles of docetaxel (AC4-D4) versus a shorter treatment of three cycles of FEC followed by three cycles of docetaxel (FEC3-D3) in node-positive breast cancer (Neo-Shorter; NCT02001506)

Hwang

Kim

Jeong

et al. 2022

Preprint

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Purpose To determine whether six cycles of FEC3-D3 has a comparable efficacy to eight of AC4-D4. Methods The enrolled patients (pts) were clinically diagnosed with stage II or III breast cancer. The primary endpoint was a pathologic complete response (pCR), and the secondary endpoints were 3-year disease-free survival (3Y DFS), toxicities, and health-related quality of life (HRQoL). Results Among the 248 pts enrolled, one case was ineligible for screening; 10 discontinued treatment due to progressive disease (7 and 3 in the AC4-D4 and FEC3-D3 arms), 16 dropped out due to a withdrawal of consent, and 3 were unable to complete the study (2 and 1 in the AC4-D4 and FEC3-D3 arms). The 218 pts who completed the surgery were included in the current analysis. The baseline characteristics of these subjects were well balanced between the two arms. By ITT analysis, pCR was achieved in 15/121 (12.4%) pts in the FEC3-D3 arm and 18/126 (14.3%) in the AC4-D4 arm (P = 0.40). With a median follow up of 64.1 months, the 3-year DFS was comparable between the two arms (77.0% in FEC3-D3 vs. 74.9% in AC4-D4; P = 0.82). The most common adverse event (AE) was Grade 3/4 neutropenia, which arose in 27/126 (21.4%) AC4-D4 arm pts vs 23/121 (19.0%) FEC3-D3 arm cases. The primary HRQoL domains were similar between the two groups (FACT-B scores at baseline, P = 0.35; at the midpoint of NACT, P = 0.20; at the completion of NACT, P = 0.44). Conclusion Both NACT AC4-D4 and FEC3-D3 show comparable outcomes in terms of pCR, three-year DFS, toxicities, and QoL Shorter neo-adjuvant FEC3-D3 could be an alternative to AC4-D4 for stage II or III operable breast cancer. Trial registration ClinicalTrials.gov NCT02001506. Registered December 5,2013 https://clinicaltrials.gov/ct2/show/NCT02001506

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Section: Discussionsupporting

confidence: 72%

Section: Discussioncontrasting

confidence: 72%

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Randomized phase III trial of a neoadjuvant regimen of four cycles of adriamycin plus cyclophosphamide followed by four cycles of docetaxel (AC4-D4) versus a shorter treatment of three cycles of FEC followed by three cycles of docetaxel (FEC3-D3) in node-positive breast cancer (Neo-Shorter; NCT02001506)

Hwang

Kim

Jeong

et al. 2022

Preprint

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“…However, for both groups, the appearance of HFS was observed in all cases during the courses of docetaxel. [ 20 ] Wardley found that 5% of patients who received herceptin with docetaxel developed HFS versus 46% of patients who received herceptin with docetaxel in combination with capecitabine. [ 21 ] Heo et al .…”

Section: Discussionmentioning

confidence: 99%

Hand–foot syndrome induced by chemotherapy drug

Zaiem

Hammamia

Aouinti

et al. 2022

Indian Journal of Pharmacology

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INTRODUCTION: Chemotherapy drugs can be responsible of several side effects such as hand–foot syndrome (HFS). This syndrome is also called “palmar-plantar erythrodysesthesia” and “acral erythema.” Without proper management, it can deteriorate the quality of life of a patient, leading to temporary or definitive stop of chemotherapy. AIM OF THIS STUDY: To identify the epidemiological and clinical characteristics of patients, the risk factors for occurrence and worsening of this syndrome, and the drugs most likely to be responsible of HFS. METHODS: Our study was retrospective, including 42 patients with HFS secondary to a chemotherapy drug. These cases were notified to the National Center of Pharmacovigilance over 7 years. The severity of HFS has been classified according to the NCI-CTCAE v4.0 classification. RESULTS: Our population was composed of 40 women and 2 men. The mean age was 51 years. Docetaxel was the main drug associated with this adverse effect. Hands were involved in all cases and were sometimes associated with other skin surfaces apart from feet. Erythema of the hands and/or feet was present in all patients; it was associated with edema in more than half of the cases. The distribution of different grades according to the NCI-CTCAE classification among the patients was almost equal: 28% Grade 1, 36% Grade 2, and 36% Grade 3. HFS occurred mainly after the first course of chemotherapy with a mean period of 3–4 days. The regression of HFS occurred more rapidly for Grade 1 and Grade 2 compared with Grade 3, especially when assisted by symptomatic treatment. The recurrence rate of HFS for those patients with decreased doses, spacing of cures, and/or symptomatic and prophylaxis treatment was 25%. CONCLUSION: An early detection of HFS, associated with preventive measures, enables patients to continue the chemotherapy.

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“…Furthermore, in our study the anthracycline administered with Ifosfamide was epirubicin and not doxorubicin; previous studies have found lower hematologic toxicity of epirubicin compared to doxorubicin. 18 Doxorubicin is the anthracycline preferred in STS chemotherapy even though cardiotoxicity and the hematologic profile could limit the use of this drug. Some studies administered epirubicin in place of doxorubicin in patients with STS with comparable therapeutic activity.…”

Section: Discussionmentioning

confidence: 99%