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R. Gunapala



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    MINI 28 - Psychological Impact of Lung Cancer and its Treatment (ID 150)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Palliative and Supportive Care
    • Presentations: 1
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      MINI28.11 - Randomised Study of Acupuncture, Morphine and Combination in NSCLC/Mesothelioma (ID 108)

      17:45 - 17:50  |  Author(s): R. Gunapala

      • Abstract
      • Presentation
      • Slides

      Background:
      Dyspnoea is a common symptom of lung cancer. Morphine is widely used to control dyspnoea.

      Methods:
      We randomised 173 patients with advanced non-small cell lung cancer or mesothelioma with a dyspnoea score ≥ 4 on visual analogue scale (VAS) to one of three arms (acupuncture [A], morphine [M] or combination [AM]). A was delivered to upper sternal, paravertebral, hand and trapezius trigger points. Patients on arm A were given rescue morphine if needed. We recorded VAS dyspnoea and relaxation, lung function tests, respiratory rate, and EORTC QLQ-30/ QLQ-LC13 questionnaires at baseline, 30mins, 90mins, 4 hours, day 2, 7 and 14. Primary endpoint was proportion of patients achieving ≥1.5 improvement in VAS dyspnoea at 4 hours.

      Results:
      The median age of the study population was 73. 53% were performance status 2-3. The baseline median VAS dyspnoea score was 6.5. All patients scored >7 on HAD depression score. 44.3% scored >10 on HAD anxiety. Dyspnoea improved by ≥1.5 points on the VAS in 74% of patients in arm A, 60% in arm M and 66% in arm AM (A versus M p-value 0.12, AM versus M p-value 0.50). On VAS scales there was improved anxiety, relaxation and tiredness of A over M. Analysis of EORTC questionnaire data showed a mean change from baseline global health % score for arm A of 7.08 compared to -2.08 for arm M (p-value = 0.009). There was a mean change from baseline in dyspnoea % score for arm A of -7.89 compared to -1.05 for arm M (p=0.029, not significant at 1% level). There was no improvement in lung function or respiratory rate. 21% of patients in arm A, 87% in arm M and 87% in arm AM took one of more doses of morphine (p<0.001). 123 patients had toxicity data. All toxicities were CTCAE grade 1/2 and in line with morphine’s toxicity profile, with 8% of patients in arm A, 35% in arm M and 39% of patients in arm AM reporting toxicities. Two patients stopped morphine because of side effects. There were two cases of skin irritation attributable to acupuncture site dressings. Score Changes from Baseline

      A M AM
      Mean VAS relaxation (SD) -1.06 (±2.60) 0.19 (±2.43) -1.48 (±2.05) p<0.001
      Day 7 median LAR relaxation (range) -1 (-6.7–4.5) 0 (-3.5–4.4) -0.9 (-5.6–4) p=0.006
      Day 7 median LAR anxiety (range) 1.5 (-2.5–8) 0 (-4–6.2) 1.2 (-5.4–6.3) p=0.003
      Mean LAR tiredness (SD) -0.82 (±2.61) 0.02 (±2.20) -0.94 (±2.37) p=0.002
      Mean EORTC global health % (SD) 7.08 (±25.54) -2.08 (±17.70) 2.72 (±16.96) p=0.009
      Mean EORTC dyspnoea % (SD) -7.89 (±17.382) -1.05 (±17.704) -6.37 (±17.797) p=0.029
      Median dose morphine (range) 32mg (1-60) 53mg (13-163) 40.63mg (3-154) p=0.007


      Conclusion:
      This study population was of poor performance status. A is as effective as M in the treatment of dyspnoea and has additive value for anxiety, relaxation and global health. Acupuncture is morphine sparing. Acupuncture should be a treatment available to lung cancer patients with dyspnoea and as a morphine adjunct.

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    P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      P2.01-077 - A Phase 1b Trial of the Combination of Capecitabine and Erlotinib in Advanced Lung Cancer (ID 239)

      09:30 - 09:30  |  Author(s): R. Gunapala

      • Abstract
      • Slides

      Background:
      Erlotinib is active in tumors with an EGFR mutation. Capecitabine, a thymidylate synthetase inhibitor, has shown some activity in advanced lung cancer (ALC). The combination of erlotinib and capecitabine has not been studied in ALC.

      Methods:
      We conducted a phase 1b trial, using a standard 3+3 dose escalation design to define the maximum tolerated dose (MTD) and safety of the combination of erlotinib and capecitabine, given on a 3-weekly cycle in 2[nd] line patients unselected for EGFR status. DLT was any grade≥2 toxicity. After MTD was defined in the 2[nd] line patients, we planned expansion of the trial to 1[st] line patients for further dose escalation. Dosing levels are listed in Table 1. Toxicity was assessed using CTCAE v3.0, response rate was assessed using RECIST 1.1, and survival assessed using Kaplan-Meier method.

      Results:
      We recruited 40 patients with adenocarcinoma. 55% were male, with median age of 67 years (range 38-84). 65% were ex-smokers and 28% were current smokers. Performance status was ECOG 1 in 65% and 2 in 35% of patients. 85% of patients had received platinum-doublet chemotherapy for 1[st] line ALC, with 10% having maintenance pemetrexed. One patient had an EGFR mutation. Dose escalation stopped at level 3 in 2[nd] line patients with expansion to 6 patients due to dose limiting toxicities (DLTs) of grade (G) 2 creatinine rise, G2 anemia, G3 atrial fibrillation, and G3 pneumonia in 2/6 patients. The MTD was thus at level 2 that was also expanded to 6 patients, confirming safety. First line patients were then recruited at MTD but resulted in DLTs in 3/4 patients with G3 troponin rise, G2 rash, and G2 bilirubin rise in 2 patients. Hence the 1[st] line approach was abandoned. The MTD in 2[nd] line patients was further expanded for toxicity and activity. The overall response rate was 3% with a disease control rate of 34%. A partial response was seen in 1 patient with EGFR mutation of 11.3 months duration. The median progressive free survival was 1.6 months (95%CI 1.4 – 3.5) and the median overall survival was 6.1 months (95%CI 5.1 – 12.5).

      Conclusion:
      The MTD for capecitabine is 750mg/m[2] bd days 1–14 and erlotinib 100mg od on a 3-weekly cycle. The addition of capecitabine does not improve the efficacy of erlotinib in unselected ALC. This combination could be explored further in ALC selected for EGFR mutation. Table 1: Patient disposition.

      Dose escalation No. of pts No. of pts with DLTs
      Level 1 - Erlotinib 100mg od, Capecitabine 500mg/m[2], bd, days 1-14 3
      Level 2 - Erlotinib 100mg od, Capecitabine 750mg/m[2], bd, days 1-14 3 + 3
      Level 3 - Erlotinib 100mg, od, Capecitabine 1000mg/m[2] bd, days 1-14 3 + 3 2
      1[st] line ALC at level 2 4 3
      Dose Expansion
      2[nd] line ALC 21


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