Quality of life, fatigue and changes therein as predictors of return to work during breast cancer treatment.

PURPOSE: To our knowledge, only one study has assessed Quality of Life (QOL) as a predictor of return to work (RTW) during breast cancer treatment and one has evaluated multidimensional cancer-related fatigue (CRF) as a determinant of RTW. However, no study has assessed the impact of changes in these variables on RTW. The objective of this study was to evaluate QOL, multidimensional CRF and changes in these variables as determinants of RTW during breast cancer treatment. METHODS: We performed a longitudinal study of 68 patients with a mean age of 46.97 years (SD = 6.92), who were employed at the time of diagnosis. Women were assessed at the beginning of adjuvant treatments (T0) and followed up with by telephone at three (T1) and 6 months later (T2), using questionnaires (QLQ-C30; MFI-20). RESULTS: Global QOL, OR = 1.12 [1.01-1.25], sleep disturbance, OR = 1.04 [1.002-1.08], fatigue (QLQ-C30), OR = 0.93 [0.88-0.99], nausea-vomiting, OR = 0.84 [0.73-0.97], reduced motivation, OR = 1.49 [1.05-2.11] and general fatigue, OR = 0.79 [0.63-0.99] at T0 were associated with RTW at T1. At T2 global QOL, OR = 1.09 [1.01-1.17], cognitive functioning, OR = 1.10 [1.03-1.17], general fatigue, OR = 1.82 [1.04-3.17] and mental fatigue, OR = 0.29 [0.11-0.81] were associated with RTW. Furthermore, changes in mental fatigue were associated with RTW at T2, OR = 0.02 [0.001-0.29]. CONCLUSIONS: Quality of life, fatigue and their changes in them, especially cognitive functioning and mental fatigue, can play an important role in predicting the RTW of women with breast cancer. This confirms the importance of multidisciplinary care for cancer and the emergence of a theoretical psychological model of RTW.

Overview of the pathological results and treatment characteristics in the first 1000 patients randomized in the SERC trial: axillary dissection versus no axillary dissection in patients with involved sentinel node.

BACKGROUND: Three randomized trials have concluded at non inferiority of omission of complementary axillary lymph node dissection (cALND) for patients with involved sentinel node (SN). However, we can outline strong limitations of these trials to validate this attitude with a high scientific level. We designed the SERC randomized trial ( ClinicalTrials.gov , number NCT01717131) to compare outcomes in patients with SN involvement treated with ALND or no further axillary treatment. The aim of this study was to analyze results of the first 1000 patients included. METHODS: SERC trial is a multicenter non-inferiority phase 3 trial. Multivariate logistic regression analysis was used to identify independent factors associated with adjuvant chemotherapy administration and non-sentinel node (NSN) involvement. RESULTS: Of the 963 patients included in the analysis set, 478 were randomized to receive cALND and 485 SLNB alone. All patient demographics and tumor characteristics were balanced between the two arms. SN ITC was present in 6.3% patients (57/903), micro metastases in 33.0% (298), macro metastases in 60.7% (548) and 289 (34.2%) were non eligible to Z0011 trial criteria. Whole breast or chest wall irradiation was delivered in 95.9% (896/934) of patients, adjuvant chemotherapy in 69.5% (644/926), endocrine therapy in 89.6% (673/751) and the proportions were similar in the two arms. The overall rate of positive NSN was 19% (84/442) for patients with cALND. Crude rates of positive NSN according to SN status were 4.5% for ITC (1/22), 9.5% for micro metastases (13/137), 23.9% for macro metastases (61/255) and were respectively 29.36% (64/218), 9.33% (7/75) and 7.94% (10/126) when chemotherapy was administered after cALND, before cALND and for patients without chemotherapy. CONCLUSION: The main objective of SERC trial is to demonstrate non inferiority of cALND omission. A strong interaction between timing of cALND and chemotherapy with positive NSN rate was observed. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov , number NCT01717131 October 19, 2012.

A Prospective Study on Skin-Sparing Mastectomy for Immediate Breast Reconstruction with Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy in Invasive Breast Carcinoma.

BACKGROUND: Skin-sparing mastectomy (SSM) with immediate breast reconstruction (IBR) is increasingly used in invasive breast cancer. However, adjuvant chemotherapy (CT) and radiotherapy (RT) can increase the rate of local complications. OBJECTIVE: The aim of this study was to assess the morbidity of SSM-IBR after neoadjuvant CT and RT. METHODS: A French prospective pilot study of women aged 18-75 years with invasive breast cancer requiring mastectomy after CT and RT. Reconstruction was performed using autologous latissimus dorsi flap with or without prosthesis. The primary endpoint was the skin necrosis rate within 6 months, while secondary endpoints included pathological complete response rate (pCR) and global morbidity. RESULTS: Among 94 patients included in this study, 83 were analyzed (mean age 45.2 ± 9.5 years, T1 23.6 %, T2 55.6 %, T3 18.1 %). All but one patient received anthracyclines and taxanes, and all patients received RT (49.3 ± 5.2 Gy) before SSM-IBR. Prostheses were used for IBR in 32 patients (mean volume 256 ± 73 mm(3)). Five patients had necrosis (≤2 cm(2), 2-10 cm(2) and >10 cm(2), in three, one, and one cases, respectively), and they all recovered without revision surgery. Among 50 patients who underwent upfront mastectomy, 36 % achieved pCR. CONCLUSIONS: SSM-IBR performed after CT and RT is safe, with an acceptable local morbidity rate. Long-term data are needed to evaluate recurrence rates.