Assessing the impact of antiemetic guideline compliance on prevention of chemotherapy-induced nausea and vomiting: Results of the nausea/emesis registry in oncology (NERO).

BACKGROUND: Evidence-based antiemetic guidelines offer predominantly consistent recommendations for chemotherapy-induced nausea and vomiting (CINV) prophylaxis. However, studies suggest that adherence to these recommendations is suboptimal. We explored inconsistencies between clinical practice and guideline-recommended treatment with a registry evaluating the effect of guideline-consistent CINV prophylaxis (GCCP) on patient outcomes. PATIENTS AND METHODS: This was a prospective, non-interventional, multicentre study. The primary objective was to assess the overall (Days 1-5) complete response (CR: no emesis/no rescue use) rates in patients who received GCCP or guideline-inconsistent CINV prophylaxis (GICP) using diaries for 5 days following chemotherapy. Cycle 1 results are presented in patients who received either (1) anthracycline/cyclophosphamide (AC) highly emetogenic chemotherapy (HEC), non-AC HEC or carboplatin, with GCCP for all these groups consisting of prophylaxis with an NK1 receptor antagonist (RA), 5-HT3RA and dexamethasone prior to chemotherapy or (2) moderately emetogenic chemotherapy (MEC), with GCCP consisting of a 5-HT3RA and dexamethasone prior to chemotherapy as per MASCC/ESMO 2016 guidelines, in place at the time of the study. RESULTS: 1,089 patients were part of the cycle 1 efficacy evaluation. Overall GCCP was 23%. CR rates were significantly higher (P < 0.05) in patients receiving GCCP (62.2%) versus GICP (52.6%) in the overall population, as well as in the subsets of patients receiving AC/non-AC HEC (60.2% versus 47.8%), MEC (73.8% versus 57.8%) and in those non-naïve to the chemotherapy received (65.9% versus 53.8%). No impact on daily living due to CINV (FLIE assessment) was observed in 43.4% patients receiving GCCP versus 28.5% GICP (P < 0.001). CONCLUSION: Consistent with prior studies, GCCP was very low; a significant benefit of almost 10% improved prevention of CINV was observed with GCCP. As per MASCC/ESMO guidelines, such an absolute difference should be practice changing. Comprehensive multifaceted strategies are needed to achieve better adherence to antiemetic guidelines.

Chemotherapy for elderly patients with advanced cancer: A pilot study in Institute of Oncology Bucharest.

OBJECTIVES: First objective was better understanding of the indications of chemotherapy in elderly with advanced cancer, tolerability and toxicity of chemotherapy in this age group. The second objective was to define current practice in chemotherapy for elderly people with advanced cancer for a selected group of patients treated in Institute of Oncology Bucharest (IOB). MATERIALS AND METHODS: The study makes a clinical analysis of medical records of 27 patients from the archive of Institute of Oncology Bucharest treated by the same doctor. Patients were selected according to: age ≥ 65 years, ECOG performance status 0-1, normal blood counts and blood biochemistry, histological confirmation of the diagnosis of cancer, patients should received at least 3 cycles of chemotherapy. We extract characteristics of the patients to see if they were a homogeneous group of patients and to compare them with data from the literature. Overall survival was calculated by the Kaplan Meyer curve. RESULTS: 295 patients more then 65 years were treated in our site in 2 years 2011, 2012. 93 patients received chemotherapy and only 27 patients were enrolled in this study following inclusion criteria. Common sites of cancer were lung and breast. The most used cytostatics for lung cancer was gemcitabine and carboplatine and cyclophosphamide, metotrexat and 5 fluorouracil for breast cancer. Toxicity was mild with the prevalence of hematologic toxicity. Overall survival without taking into account the type of cancer was 27.7 month. CONCLUSIONS: For selected patients, chemotherapy was well tolerated and appears to prolong survival regardless of the location of cancer. The relatively small number of elderly patients who received chemotherapy is probably due to lack of compliance to treatment, the increased number of co-morbidities and evaluation of performance status only by the ECOG index known not to be good enough to establish the indication of chemotherapy.

Gemcitabine (GEM) and carboplatin (CBDCA) versus cisplatin (CDDP) and vinblastine (VLB) in advanced non-small-cell lung cancer (NSCLC) stages III and IV: a phase III randomised trial.

PURPOSE: The combination of Gemcitabine (GEM)/carboplatin (CBDCA) has demonstrated activity in the treatment of stage III and IV non-small-cell lung cancer (NSCLC). This phase III randomized trial compared the response rate, survival rate, and toxicity of the combination of GEM plus CBDCA with the combination of VLB plus CDDP. METHODS: Chemonaïve patients with advanced or metastatic NSCLC were enrolled in the study. Pts were randomized by coin method to receive either cisplatin (CDDP) 70 mg/m(2) on day 1 plus vinblastine (VLB) 6 mg/m(2) on days 1 and 8 (arm A) or gemcitabine 1000 mg/m(2) on days 1 and 8 plus carboplatin 300 mg/m(2) on day 1 (arm B). Both regimens were administered on a 21-day course. RESULTS: A total of 198 patients (99 pts each in arms A and B) were enrolled in the study between July 1997 and April 2000. All pts had an ECOG performance status < or=2. Patients had a median age of 58 years (range, 49-67) in arm A and 59 years (range, 49-69) in arm B. In arm A, there were 15 partial responders (PR), for an overall response rate (ORR) of 15%, compared with three complete responders (CR) and 24 PR, for an ORR of 27% (P<0.05), in arm B. Mean survival times were 7.9 months (95% CI, 7.1-8.0) in arm A and 11.6 months (95% CI, 10.0-13.0) in arm B. One-year survival rates for arms A and B, respectively, were 13 and 36%. Numbers of pts with WHO grad 3/4 hematologic and non-hematologic toxicity in arms A/B were leukopenia 0/2, thrombocytopenia 0/2, alopecia 46/33, neurotoxicity 2/1, and asthenia 35/42. CONCLUSION: The GEM/CBDCA combination showed a higher therapeutic response, an improved 1-year survival, and a similar toxicity profile compared with the VLB/CDDP combination.