Background Randomized controlled trials (RCT) of scalp cooling (SC) to prevent chemotherapy induced alopecia (CIA) did not evaluate its effect on hair regrowth (HR) and was conducted in a predominantly taxane (T) treated population. We conducted an RCT of SC in a setting of anthracycline (A) and taxane chemotherapy (CT) and assessed its effect on CIA and HR. Methods Non-metastatic breast cancer women undergoing (neo) adjuvant CT were randomized to receive SC using the Paxman scalp cooling system during every cycle of CT, or no SC. The primary end point (PEP) was successful hair preservation (HP) assessed clinically and by review of photographs after CT. HR was assessed at 6 and 12 weeks. Results 51 patients were randomized to SC (34) or control arm (17) in a 2:1 ratio. Twenty-five (49%) patients received A followed by T and the two arms were balanced with respect to this factor. HP rate was significantly higher in SC arm compared to control arm (56.3% vs 0%, P = 0.000004). HR was higher in SC arm compared to control at 6 weeks (89% vs 12%; P < 0.001) and 12 weeks (100% vs 59%, P = 0.0003). Loss of hair at PEP evaluation, which was a quality of life measure, was significantly lower in SC versus control arm (45% vs 82%, P = 0.016). There were no grade 3–4 cold related adverse effects. Conclusions Women with breast cancer receiving A or T chemotherapy receiving SC were significantly more likely to have less than 50% hair loss after CT, superior hair regrowth and improvement in patient reported outcomes, with acceptable tolerance. It merits wider usage.
Objective:The aim of the study was to introduce and evaluate the compliance to documentation of situation, background, assessment, recommendation (SBAR) form.Methods:Twenty nurses involved in active bedside care were selected by simple random sampling. Use of SBAR was illustrated thru self-instructional module (SIM). Content validity and reliability were established. The situation, background, assessment, recommendation (SBAR) form was disseminated for use in a clinical setting during shift handover. A retrospective audit was undertaken at 1st week (A1) and 16th week (A2), post introduction of SIM. Nurse's opinion about the SBAR form was also captured.Results:Majority of nurses were females (65%) in the age group 21-30 years (80%). There was a significant association (P = 0.019) between overall audit scores and graduate nurses. Significant improvement (P = 0.043) seen in overall scores between A1 (mean: 23.20) and A2 (mean: 24.26) and also in “Situation” domain (P = 0.045) as compared to other domains. There was only a marginal improvement in documentation related to patient's allergies and relevant past history (7%) while identifying comorbidities decreased by 40%. Only 70% of nurses had documented plan of care. Most (76%) of nurses expressed that SBAR form was useful, but 24% nurses felt SBAR documentation was time-consuming. The assessment was easy (53%) to document while recommendation was the difficult (53%) part.Conclusions:SBAR technique has helped nurses to have a focused and easy communication during transition of care during handover. Importance and relevance of capturing information need to be reinforced. An audit to look for reduced number of incidents related to communication failures is essential for long-term evaluation of patient outcomes. Use of standardized SBAR in nursing practice for bedside shift handover will improve communication between nurses and thus ensure patient safety.
Background: We planned to compare pemetrexed maintenance with erlotinib maintenance in non squamous non Epidermal Growth Factor Receptor (EGFR) mutated non small cell lung cancer (NSCLC). The null hypothesis for this study was that there would be no difference in quality of life (QOL) between pemetrexed and erlotinib maintenance. Results: The QL2 scores at 3 months were 63.35 (SD 24.99) in pemetrexed arm and 63.01(SD 23.04) in erlotinib arm (p-0.793). Except in 1 domain, the scores were statistically similar between the 2 arms. In the domain of diarrhea, the score was higher as expected in the erlotinib arm (p-0.048). The median progression free survival was 4.5 months (95%CI 4.1–4.9 months) in pemetrexed arm versus 4.5 months (95%CI 3.8–5.2 months) in erlotinib arm (p-0.94). The median overall survival was 16.6 months (15.2–17.9 months) in pemetrexed arm versus 18.3 months (95% CI 13.75–22.91 months) in erlotinib arm (p-0.49). Methods: The study was an open label, single centre, parallel, phase 3 randomized study with 1:1 randomization between maintenance pemetrexed arm and erlotinib arm. Adult patients (age > or = 18 years), with non squamous EGFR mutation, treated with first line palliative therapy, with non progressive disease post 4–6 cycles of pemetrexed-carboplatin were randomized. Primary outcome was change in the score of QOL (Global health status {QL2}) at 3 months. We estimated that with 200 patients, the study had 80% power to detect a significant difference between the two groups in the change in the global health status score at 3 months with an alpha error of 5%, with an effect size of 0.3 SD. Conclusions: Maintenance pemetrexed post pemetrexed-platinum chemotherapy fails to improve QOL or time to event outcomes over maintenance erlotinib in EGFR mutation negative NSCLC.
e17003 Background: ASCT is part of standard treatment in multiple myeloma (MM).We report the results of such transplants and evaluate the role of prognostic factors if any in our patients. Methods: Sixty-one patients who underwent ASCT between June 1993 and March 2010 were included. Twenty four patients received VAD like regimen. Nineteen patients received novel agent based therapies. Ten patients underwent cyclophosphamide based mobilisation while only G-CSF based mobilisation done in 51 patients. Stem cells were harvested from peripheral blood in all patients. Melphalan was used at 200 mg/m2 in 24 patients. Prognostic factors evaluated for overall (OS) and progression-free survival (PFS) were baseline hemoglobin and albumin, ISS stage, disease status at day 100 post transplant, use of maintenance treatment post transplant, response to first line chemotherapy, use of novel agents before transplant and time to transplant from diagnosis. Results: Median age was 46 years. Median baseline haemoglobin (Hb) and albumin were 9.7 g/dl and 3.9 g/dl respectively. At the time of transplant 36% were in complete remission (CR), 5% in very good partial response (VGPR) and 28% in partial remission (PR). Median time to engraftment of neutrophils and platelets was 12 and 17 days respectively. Grade III–IV oral mucositis was seen in 35%. Transplant related mortality was 8.0 %. The 5 year overall survival (OS) and progression free survival (PFS) were 73% and 33% respectively. OS was better for patients with pre-transplant Hb greater than 9.7 g/dl (P= .04) and those who achieved CR at day 100 post transplant (P= .03). Patients who received maintenance therapy showed trend towards better OS (P= .07). PFS was better for patients with baseline albumin greater than 3.9g/dl (P = .043), Hb greater than 9.7 g/dl (P = .027) and early stage disease by ISS staging system (P=.001). Conclusions: Our study confirms that ASCT in such patients is safe and effective. Baseline albumin and Hb, ISS stage, day 100 disease response and use of maintenance treatment are important prognostic factors affecting survival.
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