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V. Bray



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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.11-002 - Toxicity of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) in the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC): A Meta-analysis (ID 292)

      09:30 - 09:30  |  Author(s): V. Bray

      • Abstract

      Background
      We performed a meta-analysis to evaluate the risk of toxic death, treatment discontinuation and grade 3 or 4 (G3/4) adverse events (AEs) of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) in the treatment of advanced non-small cell lung cancer (NSCLC).

      Methods
      Randomized trials comparing EGFR-TKI monotherapy or combination EGFR-TKI-chemotherapy with chemotherapy or placebo were included. We extracted data on toxicity events, and computed pooled relative risks (RR) adjusted for median treatment duration as the ratio of the risks in the EGFR-TKI arm versus the control group. Three treatment comparisons were analysed: EGFR-TKI versus placebo, EGFR-TKI versus chemotherapy, EGFR-TKI-chemotherapy versus chemotherapy. All statistical tests were two-sided.

      Results
      Thirty-five trials (16,507 patients) were included. EGFR-TKI was associated with 1.7% risk of toxic death (95% CI 1.4-2.0). Compared with EGFR-TKI, we demonstrated no difference in risk of toxic death for placebo (RR 1.15, 95% CI 0.08-1.86, p=0.86) or chemotherapy (RR 0.77, 95% CI 0.50–1.16, p=0.22), but higher risk for EGFR-TKI-chemotherapy compared to chemotherapy (RR 4.23, 95% CI 1.12-14.41, p=0.03). The risks of treatment-related discontinuation and G3/4 AEs were lower for EGFR-TKI than chemotherapy (RR 0.41, 95% CI 0.34-0.50, p<0.001; RR 0.35, 95% CI 0.32-0.38, p<0.001 respectively) but higher for EGFR-TKI than placebo (RR 2.43, 95% CI 1.73-3.40, p<0.001; RR 1.18, 95% CI 1.04-1.33, p=0.008) and for EGFR-TKI-chemotherapy than chemotherapy (RR 1.99, 95% CI 1.66-2.39, p<0.001; RR 1.50, 95%CI 1.32-1.70, p<0.001).

      Conclusion
      EGFR-TKI therapy in advanced NSCLC has a low incidence of toxic death and similar safety to chemotherapy with fewer serious AEs. Likelihood of benefit and careful consideration of toxicity profiles should inform treatment selection. Improved toxicity reporting in future trials would allow better quantification of EGFR-TKI-associated toxicity.

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    P1.14 - Poster Session 1 - Mesothelioma (ID 194)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Mesothelioma
    • Presentations: 1
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      P1.14-010 - Estimation of an optimal chemotherapy utilisation rate for malignant pleural mesothelioma: An evidence-based benchmark for patient care (ID 2535)

      09:30 - 09:30  |  Author(s): V. Bray

      • Abstract

      Background
      Chemotherapy has been shown to provide a survival benefit in malignant pleural mesothelioma (MPM). There are wide ranging chemotherapy utilisation rates internationally (18 – 61%). This study aims to determine the optimal proportion of patients with MPM that should receive chemotherapy at least once during the course of their illness, based on the best available evidence, so that it can be determined whether chemotherapy is under-utilised in MPM.

      Methods
      An optimal chemotherapy utilisation tree was constructed using indications for chemotherapy identified from evidence-based treatment guidelines. Epidemiological data on the proportion of patient and tumour-related attributes for which chemotherapy was indicated (resectability of the tumour, degree of comorbidities and patient performance status) were obtained and merged with the treatment indications to calculate an optimal chemotherapy utilisation rate, using the decision analysis software (TreeAge Pro 2007). Sensitivity analyses were performed to assess the impact of major variations in the epidemiological data on the overall utilisation rate. This optimal rate was compared with reported actual rates of chemotherapy utilisation in the literature.

      Results
      Chemotherapy is recommended at least once in 65% of all MPM patients. Sensitivity analyses indicate an optimal utilisation rate ranging from 50 to 65% for at least once during the course of their illness. The optimal utilisation rate is consistently higher than the reported actual chemotherapy utilisation rates in United Kingdom (18%), Netherlands (36%), United States (37%), and Australia (54%).

      Conclusion
      An evidence-based model provided an optimal chemotherapy utilisation rate for patients with MPM of 65%. It can serve as a feasible measure of the quality of cancer care. Chemotherapy appears to be under-utilised in the management of MPM in a number of high-income countries.

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    P3.12 - Poster Session 3 - NSCLC Early Stage (ID 206)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.12-009 - Patterns of care in patients receiving adjuvant chemotherapy for resected non-small cell lung cancer (NSCLC) in South Western Sydney Local Health District (SWSLHD) (ID 2093)

      09:30 - 09:30  |  Author(s): V. Bray

      • Abstract

      Background
      Randomised controlled trials have shown that adjuvant chemotherapy is the standard of care for patients with resected, stages II and IIIA NSCLC. The benefit in stage IB disease remains inconclusive. There are limited data regarding the patterns of care, benefits and toxicities of adjuvant chemotherapy in the non-clinical trial population. We reviewed patterns of care and survival outcomes in patients with resected NSCLC receiving adjuvant chemotherapy.

      Methods
      We retrospectively reviewed medical records for patients with resected, pathologic stages IB-IIIA NSCLC diagnosed between 1/1/2005 and 31/12/2012 in SWSLHD. Patients were identified using an institutional electronic database. Staging was according to the American Joint Commission on Cancer (AJCC) 6[th] edition tumour-node-metastasis (TNM) system. Information was extracted on baseline patient and tumour characteristics, treatment modalities, chemotherapy delivery, treatment-related toxicities and patient outcomes. Survival analysis was performed using Kaplan-Meier method.

      Results
      We identified 137 patients who underwent surgical resection, 63 (46%) received adjuvant chemotherapy and are presented in this analysis. The main reasons that patients did not receive adjuvant chemotherapy included stage IB disease (32%), advanced age/comorbidities (24%), patient preference (14%), prior neoadjuvant treatment (7%) and non referral (7%). The median age at diagnosis was 64 (range 45 - 77) with 57% male, 81% were ex- or current smokers and 80% had an ECOG performance status of 0 or 1. Adenocarcinoma and squamous cell carcinoma histology accounted for 54% and 27%, respectively. Forty one patients (65%) had lobectomy and 22 (35%) had pneumonectomy. Pathological stage was: 1B 5 patients (7.9%), IIA 11 (17.5%), IIB 13 (20.6%) and IIIA 34 (54%). Adjuvant chemotherapy commenced within 90 days of surgery in 94% with a median time to treatment of 60 days (range 25-110). Adjuvant radiotherapy was given to 18 patients (29%), with 52% of patients with N2 disease receiving radiotherapy. Platinum doublet chemotherapy was administered to 62 patients (98%) and cisplatin/vinorelbine was the most common regimen given to 41 patients (65%). The number of planned treatment cycles was completed by 40 patients (63%), and of these, 11 patients (17%) completed all chemotherapy on schedule without dose modification. Eighteen patients (29%) required hospitalisation during treatment. Febrile neutropaenia occurred in 10 (16%), with an additional 24 (38%) developing non-febrile neutropaenia, thrombocytopenia or anaemia. Other clinically significant non-haematological toxicities included: vomiting (11%); renal impairment (10%); ototoxicity (6%); peripheral neuropathy (16%); fatigue (6%); allergy (2%) or myalgias (3%). There were no toxic deaths. With a median follow-up of 18.6 months (range 3.4 to 96 months), 56% had developed recurrent disease with a median disease-free survival of 18.9 months. The majority (94%) developed recurrent disease within 3 years. The median overall survival was 25.6 months. A total of 34 (54%) had died, including 3 non-cancer related deaths.

      Conclusion
      The utilisation of adjuvant chemotherapy rate is moderate but is consistent with other reports. Our results demonstrated a higher rate of febrile neutropenia and shorter median overall survival than the clinical trial population. Therefore, careful selection of patients to undergo adjuvant chemotherapy is essential.