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B. Melosky



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    O15 - NSCLC - Chemotherapy II (ID 109)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      O15.01 - Evaluation of a "watch and wait" approach for patients with newly diagnosed advanced non-small cell lung cancer in a diverse community population (ID 2384)

      10:30 - 10:40  |  Author(s): B. Melosky

      • Abstract
      • Presentation
      • Slides

      Background
      The current treatment paradigm for metastatic non-small cell lung cancer (NSCLC) includes systemic therapy, radiotherapy or both. A “watch and wait” approach (WW) is commonly used in clinical practice. Whether this approach would have any effect on survival outcomes has not previously been evaluated.

      Methods
      The British Columbia Cancer Agency (BCCA) provides comprehensive cancer care to a population of 4.5 million across 944735 sq kms. A retrospective review was conducted of all referred patients diagnosed with stage IIIb/IV NSCLC from January to December 2009 in BC who saw a medical oncologist (MO). Patient characteristics, treatment recommendations, and outcomes were abstracted. WW-treated is defined as initial observation with chemotherapy > 8 weeks from MO consult. WW-missed are patients who were on a WW strategy that did not receive chemo. Kaplan-Meier survival analysis was compared using log rank test. Cox proportional hazards modeling was used to evaluate prognostic factors and control for potential confounders.

      Results
      710 patients were seen by a MO. Median age 66 years (29-90), ECOG 0-1 51%, male 52%, non squamous/squamous/NOS 40%/19%/41%, rural/urban 19%/81%. 327 received upfront chemo, 171 WW and 209 deemed chemo ineligible due to poor ECOG, and comorbidities. Of the 171 patients on a WW approach 44% missed an opportunity for chemotherapy (Figure 1). Reasons for WW-missed included poor ECOG (50%), death (47%), asymptomatic (1%), and illness (1%). Median OS was highest in the WW-treated 16.5 months (CI 12.7-20.3), followed by 13.9 months (CI 12.0-15.8) in the upfront chemo and lowest in the WW-missed 5.9 months (CI 4.4-7.4), p<0.0001. On multivariate analysis, factors predicting a poorer OS included ECOG >2, squamous histology, and a shorter the time from diagnosis to referral and referral to MO consult. When controlled for confounding factors (age, sex, ECOG) OS was similar between the upfront chemo and WW-treated (HR 1.16, CI 0.849-1.58, p=0.353), while those who were in the WW-missed had a significantly lower OS (HR 5.54, CI 3.00-10.24, P<0.0001). Figure 1

      Conclusion
      Our study demonstrates that a “watch and wait” strategy is potentially detrimental to patients because a significant proportion never receives chemotherapy. A decline in ECOG status accounts for 50% of the “missed” chemotherapy. Frequent follow up should be employed for patients who are on a WW approach to ensure the window of opportunity for chemotherapy is not lost.

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    P2.10 - Poster Session 2 - Chemotherapy (ID 207)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.10-015 - Less toxic chemotherapy improves uptake of all lines of chemotherapy in advanced non small cell lung cancer, particularly in the elderly: A ten year retrospective population-based review (ID 1066)

      09:30 - 09:30  |  Author(s): B. Melosky

      • Abstract

      Background
      The platinum doublet is standard first-line therapy in advanced NSCLC. Over the past decade, well tolerated second-line therapies have been approved including erlotinib and pemetrexed. We hypothesize that the introduction of less toxic chemotherapy has increased treatment of advanced NSCLC resulting in improved survival.

      Methods
      The BC Cancer Agency provides cancer care to a population of 4.5 million. A retrospective review was conducted of all referred Stage IIIB/IV patients in four 1 yr time cohorts; C1 baseline (1998) and 6 months after the provincial approval of C2 docetaxel (2001), C3 erlotinib (2006) and C4 pemetrexed (2007).

      Results
      2, 623 patients were referred and 720 had systemic therapy. Characteristics: M/F 55%/45%, median age 67 (33-101), ECOG <=1/>=2/unknown 33%/56%/11%, never/former/current/unknown smoker 9%/35%/36%/20%, squam/nonsquam/NOS 18%/41%/41%. More patients received first line chemotherapy over time; 16%, 23%, 34%, 33% C1-4 respectively. In C1 to C4 uptake of second line (21%, 27%, 38%, 55%) and third line (10%, 10% 14%, 18%) increased. In C1 the most common first line doublet was cis/vino (70%) and in C4, cis/gem (45%). Second line doce was frequently used in C2 (51%) but usage decreased in C4 to 7% vs. erlo 50% and pem 26%. In the >=70 group (n=1118), 1[st] line usage increased from C1 9% to C4 19% and 2[nd]line in the C2 (doce) 4% to C4 (erlo+pem avail) 56%. The increased use of systemic therapy was associated with improved survival in all patients: C1 4.56 m vs C4 4.98 m (p=0.004) and treated patients; C1 9.48 m vs C4 12.07 m (p=0.014) and the >= 70 group; C1 9.7 m vs C4 12.5 m (p=0.07).

      Conclusion
      This population-based data set represents the trend of treatments over time in a large geographical area, including community and tertiary care cancer treatment sites. The introduction of less toxic systemic therapy for advanced NSCLC resulted in an increased proportion of patients treated with first-line chemotherapy and an even greater increase in 2nd/3rd line treatment. This trend was particularly evident in the elderly. Associated with this was a significant improvement in overall survival for all subsets.

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    P3.10 - Poster Session 3 - Chemotherapy (ID 210)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.10-048 - Referral patterns in advanced non small lung cancer: Impact on delivery of treatment and survival in British Columbia (ID 2931)

      09:30 - 09:30  |  Author(s): B. Melosky

      • Abstract

      Background
      Chemotherapy improves overall survival in advanced non-small cell lung cancer (NSCLC). We sought to evaluate clinical effectiveness of chemotherapy in the general population by looking at referral patterns, and outcomes.

      Methods
      The British Columbia (BC) Cancer Agency is a publicly funded system that serves a population of over 4.5 million. All referred cases of stage IIIb/IV non-small cell lung cancer were identified using the BC Outcomes and Surveillance Integrated System and retrospectively reviewed. Patient demographics, tumour characteristics and treatments were extracted. Overall survival (OS) was estimated using the method of Kaplan-Meier. Cox Proportional Hazards (CPH) modeling was used to control for possible confounders. Multiple logistic regression (MLR) was used to compare characteristics between patients who were referred and not referred to a medical oncologist (MO).

      Results
      1384 patients were diagnosed with Stage IIIb/IV NSCLC between January 1 to December 31, 2009. Median age 70 years (29-96), male 53%, ECOG 0-1 38%, rural/urban 17%/83%, non-squamous/squamous/NOS 34%/21%/46%. 710 (51%) patients were assessed by a MO and of these, 382 (54%) received chemotherapy. 1225 (89%) were assessed by a radiation oncologist (RO), and 1025 (84%) received radiation. MLR showed that patients referred to MO were more likely to be younger, from an urban area, and have a better ECOG. Median OS for the entire cohort was 9.6 months (CI 8.5-10.7). There was a statistically significant improvement in OS in patients who received chemotherapy at 14.2 months (CI 12.5-15.9) in comparison to 7.6 months (CI 6.6-8.6) who did not receive chemotherapy (p<0.0001). This remained statistically significant in the CPH model, controlling for ECOG, sex, age, histology (HR 0.80, CI 0.65-0.92). In comparison, OS was 8.6 months (CI 7.4-9.8) for patients who received only radiotherapy, and 5 months (CI 3.1-6.8) for those treated with best supportive care.

      Conclusion
      Only half of the referred patients were assessed by a medical oncologist and only 54% of them received chemotherapy. This is despite the awareness that chemotherapy significantly improves OS. Strategies to improve upon this 51% referral rate should be evaluated, such that patients do not miss out on life-prolonging therapy.

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    P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.11-049 - Afatinib in advanced pretreated NSCLC - a Canadian experience (ID 3460)

      09:30 - 09:30  |  Author(s): B. Melosky

      • Abstract

      Background
      Afatinib is an oral, irreversible pan-EGFR inhibitor with demonstrated superiority over first-line chemotherapy in advanced EGFR mutation positive NSCLC. It is also active after failure of chemotherapy and reversible EGFR tyrosine kinase inhibitor (TKI) therapy, with higher response rate and better progression-free survival than placebo (LUX-Lung 1, Miller et al. Lancet Oncol. 2012). Through a national special access program (SAP), Canadian patients with advanced NSCLC, similar to those in the LUX-Lung 1 trial, may access afatinib after exhausting all other available therapies. We report our Canadian experience with afatinib at the two largest centres participating in the SAP.

      Methods
      Retrospective chart review of SAP participants was undertaken at 2 major Canadian cancer centres, the British Columbia Cancer Agency (Vancouver) and Princess Margaret Cancer Centre (Toronto). Demographic, disease and treatment data were abstracted, including toxicity, response (clinically documented tumour reduction), treatment duration and overall survival.

      Results
      From July 2010 to the present, 54 patients at the two sites were treated with afatinib through the SAP. Median age was 59.5 (range 37 to 88 years), 57% were female, 52% were never smokers (7% current, 35% former smokers), 67% had adenocarcinoma histology and 28% were East Asian. 26% had known EGFR mutations (7% wild type, 67% unknown), most commonly exon 19 deletions. Patients received a median of 3 previous therapies (range 2 to 5). All had received prior EGFR TKI therapy (81% erlotinib, 11% gefitinib, 6% both, 2% dacomitinib). Half (47%) had a response to prior EGFR TKI therapy, and 37% experienced grade ≥2 rash and 9% grade ≥2 diarrhea on prior EGFR TKI. The median time from metastatic diagnosis to starting afatinib was 23.1 months. The median treatment duration was 2 months (range 0 – 26). 21% of patients had a response (tumour reduction) to afatinib, 20% stable disease and 50% disease progression as their best response. Median survival from the time of afatinib start was 5 months (95% CI: 2-12 months). The average starting dose of afatinib was 40 mg (6% 50 mg, 94% 40 mg), with 11% requiring dose reduction. One third of patients (34%) stopped treatment for disease progression, 17% for toxicity, 30% for clinical deterioration and 19% for other or unknown reasons. The rate of grade ≥2 diarrhea, rash, paronychia, or stomatitis with afatinib was 17%, 20%, 9%, and 9% respectively (grade ≥3 in 10%, 11%, 5% and 5%). Response (non-RECIST) to afatinib was seen in EGFR wild type (2/4) and mutation positive (3/13) patients. Response to erlotinib or gefitinib was non-significantly associated with response to afatinib (OR 3.3, p=0.22). A similar non-significant association was seen with rash (OR 1.7, p=0.22), but not with diarrhea, (OR 0.37, p=0.45).

      Conclusion
      Afatinib demonstrates activity in clinical practice similar to that reported in LUX-Lung 1. While some required dose reduction, toxicity from afatinib appeared manageable for the majority. Although not significant, there was a propensity to experience response or rash on afatinib if seen with prior EGFR TKI, although this was not seen with diarrhea.