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A. Joshi



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    P1.09 - Poster Session 1 - Combined Modality (ID 212)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Combined Modality
    • Presentations: 1
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      P1.09-006 - Chemo-Radiotherapy For Locally Advanced NSCLC In Resource Limited Population: Is It Isoeffective? (ID 836)

      09:30 - 09:30  |  Author(s): A. Joshi

      • Abstract

      Background
      Annually 63,000 approximately new patients of lung cancer are diagnosed in India, with two-third of them in advanced stage at presentation.. Radiotherapy with concurrent chemotherapy has shown survival benefit and is the standard of care for this group of patients in western literature.

      Methods
      One hundred seventy four consecutive patients Of Non Small cell Lung cancer (NSCLC) were treated with radical (chemo)-radiotherapy at Tata Memorial hospital from January 2008 to December 2012, . Detailed study of patient, tumour and treatment related factors were performed. Outcomes in the form of progression free survival (PFS) and overall survival (OS) at two years were calculated. Follow-up and analysis of data was performed in February 2013. Univariate and multivariate analysis was performed to see the impact of patient related factors like age, smoking, KPS, presence of comorbidity, tumour related factors including T stage, N stage and stage group and treatment related factors chemotherapy timing , total dose, duration of radiotherapy and response to treatment on PFS and OS.

      Results
      Of 174 patients, Males were 154(88.5%) with median age of 58 years (range 30-84 years) and 121(69.5%) were smokers. Median KPS was 80 (range 60-100) and 59 patients had significant comorbidity. Cough was the commonest presenting symptom (28%) followed by chest pain (27%) and haemoptysis (24.7%). Most common histology was squamous carcinoma 47.1% followed by adenocarcinoma in 41.4%. Stage III (A+B) constituted 90.2% of the patients. All patients received thoracic radiotherapy using 3D Conformal technique using 6/15 MV photons to a median dose of 60Gy (range 4-66Gy) over a median duration of 44 days(2-85 days) .Of 174 patients 166 patients (95.4%) completed the planned treatment. Median GTV and PTV volumes were 132 cc (16.7-741cc) and 538 cc(56-5680 cc) respectively. The median lung-PTV volume was 2599cc and V20 Gy was 23.79 %. Out of 174 patients 76% patients received concurrent chemotherapy, while 11.5% received sequential chemotherapy also. Response assessment using WHO criteria was done at 2 months post treatment, 63 (36.1%) had complete response whereas 64patients (36.8%) had partial response or stable disease and 7 patients(3.4%) had progressive disease . At last follow-up of with mean follow up 9.3 months (range 0-37 months), 32 patients had loco-regional recurrence and 33 patients had distant metastases. Acute pneumonitis grade I and II was observed in 87(50%) and 13(7.4%), acute oesophagitis grade II and III was seen in 56(32.1%) and 7(4%) patients respectively as per RTOG grading. Median PFS and OS were 20 months and 23 months with the estimated 2 year PFS & OS was 35% & 47.4%respectvely.On Univariate analysis, complete response to treatment (p=0.000) had favourable impact on PFS whereas smoking (p=0.009), advanced T stage (p=0.002) and less than complete response (p=0.000) had negative impact on OS.

      Conclusion
      Even under resource limited conditions patients who were treated with an intensive (chemo) radiation with supportive care had an acceptable treatment compliance and comparable treatment outcomes. , Patients with advanced stage and smokers did worse. Patients treated with concurrent chemoradiation and complete responders had better OS.

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    P1.10 - Poster Session 1 - Chemotherapy (ID 204)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.10-030 - Comparative Pharmacokinetics of Two Formulations of Pemetrexed in Indian Adult Chemo-Naive, Adenocarcinoma Non-Small Cell Lung Cancer Patients. (ID 1565)

      09:30 - 09:30  |  Author(s): A. Joshi

      • Abstract

      Background
      Pemetrexed (Alimta, Eli Lilly) with platinum doublet is an effective drug for first-line treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). Innovator products are generally highly priced which limits their utility in developing countries. In India, a generic formulation (Pemgem, Dr. Reddy’s Laboratories) is marketed at 25% the cost of Alimta. Results of a study comparing the pharmacokinetic and safety profile of the two formulations of pemetrexed are discussed here.

      Methods
      This study was approved by TMC-ACTREC-IRB and registered with Clinical Trials Registry- India (CTRI). Patients were enrolled from a tertiary care cancer hospital in India as per predefined selection criteria mentioned the protocol. Pemetrexed (500 mg/m[2]) was administered as a 10 minute short infusion. All patients received standard premedication. Pharmacokinetic blood samples were collected at predose and 10 minutes (just before end of infusion), 15 min., 30 min., 50 min., 1 hr., 1 hr. 20 min., 2 hrs.,4 hrs.,6 hrs., 8 hrs. and 24 hrs after starting the infusion. Plasma pemetrexed levels were determined by a validated HPLC method. Toxicity was graded using CTCAE v. 4.03. Quality of life questionnaire was taken at baseline and at end of 3rd cycle.

      Results
      Twenty four patients were enrolled on the study, eight in Alimta arm and sixteen in Pemgem arm. Patient demographics were comparable in the two arms. Mean Area Under the Concentration-Time Curve (AUC~0-24 hr~) was 222.06 vs. 253.7 mg h/L and mean C~max ~was 106.5 and 130.7 mg/L in Pemgem and Alimta arms respectively. Volume of distribution of pemetrexed was 16.59 and 17.56 L, clearance was 3.83 vs. 4.3 L/hr and half-life was 3.29 and 2.43 hr in the two arms respectively. Toxicity was comparable between the groups. However, a higher incidence of grade III/IV hyponatrimia (25%) was observed in our patients which needs to be investigated further. Global health status improved significantly in both treatment arms at the end of 3 cycles compared to baseline. Pooled data of selected Quality of Life indices is shown below. Table 1: Mean difference in selected Quality of Life indices (3rd Cycle Vs. Baseline)

      QOL scale Mean difference SEM P value
      Global health status 18.39 3.10 0.001
      Pain -7.77 3.46 0.023
      Dysponea -7.77 3.81 0.05
      Insomnia -4.44 3.06 0.017
      Haemoptysis -3.33 2.10 0.043

      Conclusion
      Pemgem had similar pharmacokinetic and safety profile as Alimta. Generic substitution would be cost effective and likely to yield comparable efficacy.