PURPOSE Patients with triple-negative breast cancer (TNBC) and residual invasive disease (RD) after completion of neoadjuvant chemotherapy (NAC) have a high-risk for recurrence, which is reduced by adjuvant capecitabine. Preclinical models support the use of platinum agents in the TNBC basal subtype. The EA1131 trial hypothesized that invasive disease-free survival (iDFS) would not be inferior but improved in patients with basal subtype TNBC treated with adjuvant platinum compared with capecitabine. PATIENTS AND METHODS Patients with clinical stage II or III TNBC with ≥ 1 cm RD in the breast post-NAC were randomly assigned to receive platinum (carboplatin or cisplatin) once every 3 weeks for four cycles or capecitabine 14 out of 21 days every 3 weeks for six cycles. TNBC subtype (basal v nonbasal) was determined by PAM50 in the residual disease. A noninferiority design with superiority alternative was chosen, assuming a 4-year iDFS of 67% with capecitabine. RESULTS Four hundred ten of planned 775 participants were randomly assigned to platinum or capecitabine between 2015 and 2021. After median follow-up of 20 months and 120 iDFS events (61% of full information) in the 308 (78%) patients with basal subtype TNBC, the 3-year iDFS for platinum was 42% (95% CI, 30 to 53) versus 49% (95% CI, 39 to 59) for capecitabine. Grade 3 and 4 toxicities were more common with platinum agents. The Data and Safety Monitoring Committee recommended stopping the trial as it was unlikely that further follow-up would show noninferiority or superiority of platinum. CONCLUSION Platinum agents do not improve outcomes in patients with basal subtype TNBC RD post-NAC and are associated with more severe toxicity when compared with capecitabine. Participants had a lower than expected 3-year iDFS regardless of study treatment, highlighting the need for better therapies in this high-risk population.
Context Black patients are more likely than white patients to die in the intensive care unit with life-sustaining treatments. Differences in patient- and/or surrogate-provider communication may contribute to this phenomenon. Objectives To test whether hospital-based physicians use different verbal and/or nonverbal communication with black and white simulated patients and their surrogates. Methods We conducted a randomized factorial trial of the relationship between patient race and physician communication using high-fidelity simulation. Using a combination of probabilistic and convenience sampling, we recruited 33 hospital-based physicians in western Pennsylvania who completed two encounters with prognostically similar, critically and terminally ill black and white elders with identical treatment preferences. We then conducted detailed content analysis of audio and video recordings of the encounters, coding verbal emotion-handling and shared decision-making behaviors, and nonverbal behaviors (time interacting with the patient and/or surrogate, with open vs. closed posture, and touching the patient and physical proximity). We used a paired t-test to compare each subjects’ summed verbal and nonverbal communication scores with the black patient compared to the white patient. Results Subject physicians’ verbal communication scores did not differ by patient race (black vs. white: 8.4 vs. 8.4, P-value = 0.958). However, their nonverbal communication scores were significantly lower with the black patient than with the white patient (black vs. white: 2.7 vs. 2.9, P-value 0.014). Conclusion In this small regional sample, hospital-based physicians have similar verbal communication behaviors when discussing end-of-life care for otherwise similar black and white patients but exhibit significantly fewer positive, rapport-building nonverbal cues with black patients.
Background: Framing is known to influence decision making. Objective: The study objective was to describe language used by physicians when discussing treatment options with a critically and terminally ill elder. Methods: High-fidelity simulation was used, involving an elder with end-stage cancer and life-threatening hypoxia, followed by a debriefing interview. Subjects were hospitalist, emergency medicine, and critical care physicians from three academic medical centers. Measures were observation of encounters in real time followed by content analysis of simulation and debriefing interview transcripts. During the simulation we identified the first mention (''broaching'') of principal treatment options-intubation and mechanical ventilation (lifesustaining treatment [LST]) and palliation in anticipation of death (palliation)-and used constant comparative methods to identify language used. We identified physician opinions about the use of LST in this clinical context during the debriefing interviews, and compared language used with opinions. Results: Among 114 physician subjects, 106 discussed LST, 86 discussed palliation, and 84 discussed both. We identified five frames: will (decided), must (necessary), should (convention), could (option), and ask (elicitation of preferences). Physicians broached LST differently than palliation ( p < 0.01), most commonly framing LST as necessary (53%), while framing palliation as optional (49%). Among physicians who framed LST as imperative (will or must), 16 (30%) felt intubation would be inappropriate in this clinical situation. Conclusions: In this high-fidelity simulation experiment involving a critically and terminally ill elder, the majority of physicians framed the available options in ways implying LST was the expected or preferred choice. Framing of treatment options could influence ultimate treatment decisions.
Staging System [24] and chromosomal abnormalities determined by standard metaphase karyotype and/or fluorescence in situ hybridization (FISH). Treatment-induced adverse events were graded according to the National Cancer Institute common terminology criteria for adverse events (CTCAE) version 4.0. For response assessment we utilized the International Uniform Response Criteria for Mutiple Myeloma [25]. The main endpoint of the study was to determine the overall response rate for high-dose cyclophosphamide in bortezomib-refractory MM patients. Secondary endpoints were to determine median overall survival, frequency and severity of adverse events. Progression free survival and duration of response was not estimated since this endpoint was distorted by the high proportion of patients undergoing transplantation immediately after a response was obtained. We reported proportions with their respective 95% confidence intervals. Continuous numerical variables were described using their median and range. Overall survival was described utilizing the method of Kaplan-Meier. Statistical analysis was performed the software SPSS (version 16).
Exposure to Agent Orange (AO) has been associated with the development of chronic lymphocytic leukemia (CLL). We performed a retrospective study of 2052 Vietnam veterans identified in the National VA Tumor Registry to assess the impact of AO exposure on CLL prognosis, treatment and survival. Prognostic factors did not differ based on exposure. Veterans exposed to AO were diagnosed younger (63.2 vs. 70.5 years, p < .0001) and had longer overall survival (median not reached vs. 91 months, p < .001). This prolonged survival was in the subgroups of patients aged 60-69 years (p< .0001) and those with 11q deletion (p < .0001). Those exposed to AO were more likely to be treated with fludarabine, chlorambucil and rituximab (38 vs. 21%, p < .001) and bendamustine plus rituximab (25 vs. 18%, p = 0.039) as first line therapy. Exposure to AO was not associated with either poor prognostic factors or shortened overall survival in our large veteran population with CLL.
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