Compression therapy using surgical gloves does not prevent paclitaxel-induced peripheral neuropathy: results from a double-blind phase 2 trial.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of paclitaxel (PTX). There is no known prophylactic measure, although there are some reports of prevention with compression therapy using surgical gloves. On account of its predominantly subjective symptoms, it is difficult to exclude bias when assessing for CIPN. In this study, we assessed the effectiveness of the same procedure for the prevention of paclitaxel-induced PN based on a double-blind study design. METHODS: The patients with early and recurrent breast cancer (with no prior PTX exposure) initiating weekly chemotherapy with PTX 80 mg/m2 were enrolled. Each patient donned two gloves on each hand at every PTX infusion. Two one-size-smaller gloves were donned on one hand (study side) and two normal-size gloves were donned on the other hand (control side) during 90 min from 30 min before the infusion to 30 min after the end of the infusion. Study side are blind for both patients and assessing physicians according to determination of the study side by research nurses in the chemotherapy unit. The primary outcome was the difference in the frequency of CIPN (motor/sensory) determined by the physician using the common terminology criteria for adverse events (CTCAE v4.0), with an evaluation at each cycle of PTX infusion. McNemar test was used to assess the primary outcome. RESULTS: Between July 2017 and November 2018, 56 patients were enrolled and 49 patients were evaluated. Overall, Grade ≥ 2 PN (sensory) was observed in 30.6 and 36.7% in the study and control sides, respectively (McNemar p = 0.25). PN (motor) was observed in 4.1 and 6.1% in the study and control sides, respectively (McNemar p = 1.0). CONCLUSION: Surgical glove compression therapy showed no statistically significant effect on the incidence of PTX-induced PN. TRIAL REGISTRATIONS: This study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry managed by the National University Hospital Council of Japan ( UMIN000027944 ). Registered 26 June 2017.

High recurrence risk and use of adjuvant trastuzumab in patients with small, HER2-positive, node-negative breast cancers.

BACKGROUND: Five randomized trials of adjuvant trastuzumab have reported significant improvements in recurrence-free survival (RFS) and overall survival. However, patients with node-negative tumors 1 cm or smaller were excluded from these trials. We assessed the recurrence risk and benefit of adjuvant therapy in such patients with small tumors. METHODS: We identified patients with node-negative breast tumors 1 cm or smaller between April 2003 and December 2007. Patients were categorized according to HER2 status and pathological tumor size (pT <5 mm vs. 5-10 mm), hormone receptor (HR) status and adjuvant chemotherapy. The primary endpoint was RFS. RESULTS: Of 267 patients included in the analysis, 42 had HER2-positive tumors. The median follow-up was 4.3 years. RFS was worse in patients with HER2-positive tumors than HER2-negative tumors (90.5 vs. 97.7% at 5 years; P = 0.031). In the group with HER2-positive tumors, there were no recurrences in patients with pT<5 mm, but 4 recurrences in those with pT 5-10 mm. RFS was worse in patients with pT 5-10 mm than pT <5 mm (79.0 vs. 100%, P = 0.025). Furthermore 3 recurrences occurred in patients without adjuvant trastuzumab, and 1 recurrence occurred as soon as adjuvant trastuzumab was finished. Our results appear to establish the efficacy of adjuvant trastuzumab therapy. HR status and use of adjuvant chemotherapy were not significantly associated with RFS. CONCLUSIONS: Patients with HER2-positive, node-negative breast tumors 1 cm or smaller (especially 0.5-1.0 cm) have a significant recurrence risk and the decision to employ adjuvant trastuzumab therapy should be discussed with patients based on our results and those of other studies.

Sentinel lymph node biopsy is not necessary in patients diagnosed with ductal carcinoma in situ of the breast by stereotactic vacuum-assisted biopsy.

BACKGROUND: This study evaluated the role and need of a sentinel lymph node biopsy (SLNB) in patients with an initial diagnosis of ductal carcinoma in situ (DCIS) made by stereotactic vacuum-assisted biopsy (VAB). MATERIALS AND METHODS: A retrospective analysis was performed of 1,458 patients who underwent stereotactic VAB between January 1999 and December 2012 at Aichi Cancer Center Hospital. The rates of axillary node metastasis and the underestimation of invasive ductal carcinoma (IDC) were examined. RESULTS: Of the 1,458 patients who underwent stereotactic VAB, 199 had a preoperative diagnosis of DCIS and underwent surgery. In these patients, 20 % (39/199) were upstaged to IDC or at least microinvasion in final pathology. Axillary lymph node status was investigated in 81 % (161/199) of initially diagnosed DCIS patients, and resulted in finding lymph node metastasis in 0.62 % (1/161) patients. To assess the potential preoperative predictors of invasiveness, the value of DCIS histological grade on biopsy samples, the distribution of calcifications on mammograms, and the combination of these factors were studied. The underestimation rate was higher (30 %) in the combination of high DCIS histological grade and extensive calcification although there was no significant association (p = 0.23). CONCLUSION: The rate of lymph node metastasis was extremely low (0.62 %), even when invasive carcinoma was identified on excision in patients initially diagnosed with DCIS by stereotactic VAB. Because of the low prevalence of metastatic involvement, the cessation of SLNB is a reasonable consideration in patients initially diagnosed with DCIS by stereotactic VAB.