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S. Thongprasert



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    MS19 - New Health Technology for Lung Cancer; Assessment and Implementation (ID 36)

    • Event: WCLC 2013
    • Type: Mini Symposia
    • Track: Radiation Oncology + Radiotherapy
    • Presentations: 1
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      MS19.3 - Resource Constraints as a Barrier to Lung Cancer Management: Developing Nations (ID 548)

      14:45 - 15:05  |  Author(s): S. Thongprasert

      • Abstract
      • Presentation
      • Slides

      Abstract
      Resource Constraints is an important barrier to Lung Cancer Management. In order to understand this issue in Developing Nations, the questionnaires was set up and send to an experts in Asian countries to find out the fact about this issues. Data gather from the questionnaires will be present at the meeting. Specific information in the questionnaires are Drug lagging period, time to get new cancer drug approval, the important of economic analysis during the approval of new anticancer drug. The other information related to man power including specialist in all related subspecialties and the availability and accessibilty to diagnostic and treatment will be captured by questionnaires. Pattern of Health Insurance and other cost was also the information gathered at the same time.

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    O04 - Molecular Pathology I (ID 126)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Pathology
    • Presentations: 1
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      O04.05 - Epidemiology of PI3K pathway alterations in patients with metastatic non-small cell lung cancer (NSCLC): findings from the international BASALT-1 study (ID 1810)

      11:15 - 11:25  |  Author(s): S. Thongprasert

      • Abstract
      • Presentation
      • Slides

      Background
      Buparlisib (BKM120) is an oral PI3K inhibitor that inhibits all four isoforms of class I PI3K (α, β, γ, δ) and has demonstrated antiproliferative, proapoptotic, and antiangiogenic activity in multiple preclinical cancer models. NSCLC cell lines with PIK3CA mutations (muts) have demonstrated increased sensitivity to buparlisib in vitro. BASALT-1 – an ongoing, multicenter, open-label, two-stage Phase ll study (NCT01297491) – evaluates the safety and efficacy of single-agent buparlisib in patients (pts) with NSCLC and an activated PI3K pathway. Here we report data on the prevalence of PI3K pathway alterations in pts with squamous (sq) or non-squamous (non-sq) NSCLC prescreened for entry into BASALT-1.

      Methods
      Pts prescreened for BASALT-1 were ≥18 years of age with previously treated metastatic NSCLC of sq or non-sq histology. PI3K pathway activation (defined as PIK3CA mut and/or PTEN mut and/or PTEN negative [neg; <10% protein expression at 1+ by immunohistochemistry]) was measured in archival or newly acquired tumor tissue collected at prescreening. PIK3CA (exons 1, 5, 7, 9, and 20) and PTEN (exons 1–9) muts were detected primarily using Sanger sequencing in a centralized fashion. Local analysis was permitted at selected sites where a SnapShot approach was most commonly used.

      Results
      As of April 10, 2013, 1183 pts had submitted tumor samples to be assayed (1179 tumors had known histology). PI3K pathway activation was detected in 16.0% of sq and 11.3% of non-sq tumors. In sq tumors (N=612), loss of PTEN protein expression (8.2%) was the most common single alteration observed, followed by PIK3CA mut only (3.1%) and PTEN mut only (2.9%). In non-sq tumors (N=567), PTEN mut only was the most common alteration (4.9%), followed by PIK3CA mut only (2.6%) and PTEN neg only (2.1%). Frequencies of co-existing genetic alterations were: PTEN mut + PTEN neg only (1.0% sq vs 0.4% non-sq), PIK3CA mut + PTEN neg only (0.7% sq vs 0.4% non-sq), PIK3CA mut + PTEN mut only (0% sq vs 0.9% non-sq), and PIK3CA mut + PTEN mut + PTEN neg (0.2% sq vs 0% non-sq). No clear gender, age or ethnicity effects were observed (Table). Figure 1

      Conclusion
      The findings from our large dataset indicate that genetic alterations in the PI3K pathway occur in a clinically significant proportion of pts with sq and non-sq relapsed NSCLC. An accurate characterization of PI3K pathway alteration frequencies in NSCLC will help guide the design of future clinical trials of PI3K inhibitors.

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    P3.24 - Poster Session 3 - Supportive Care (ID 160)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Supportive Care
    • Presentations: 2
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      P3.24-030 - Activity and tolerability of carboplatin and gemcitabine in first-line treatment of elderly Thai patients with advanced non-small cell lung cancer (NSCLC). (ID 1930)

      09:30 - 09:30  |  Author(s): S. Thongprasert

      • Abstract

      Background
      Despite the rising incidence of NSCLC in the elderly population in Thailand, a well defined chemotherapy regimen for these patients has not been reported. This study examines the toxicity and activity of doublet carboplatin and gemcitabine in Thai patients with advanced NSCLC.

      Methods
      Chemotherapy-naive patients with histological/cytological proven advanced NSCLC, aged > 65 years, ECOG 0-1 and adequate organs function were treated with carboplatin (AUC5) and gemcitabine (1000 mg/m[2] in a 30-min infusion D1, 8) every 21 day for maximum 6 cycles. The primary endpoint was objective tumor response rate and tolerability to this regimen.

      Results
      From November 2011 to February 2013, 30 patients were evaluated. Median age was 73 years (range 65-83), 70% were male, 70% were smoker and all patients had PS 0 (30%) or PS 1 (70%). Stage IIIb disease in 13% patients and stage IV in 87% patients. Non-squamous cell carcinoma in 73% patients (adenocarcinoma 66%, large cell carcinoma 3.5%, other 3.5%) and squamous cell carcinoma in 27% patients. The median number of cycle was 4 (range 2-6). Among the 29 patients with measurable disease, there were 7 PR, 15 SD and 7 PD (response rate 24%). The most common hematologic toxicity was grade 3 anemia in 20% and grade 3 leukopenia in 10%. Febrile neutropenia occurred in 3%. No treatment related death was observed. Non-hematologic toxicity was generally mild and grade 1 fatigue occurred in 30%. The median progression free survival was 4.9 months (range 2-16).

      Conclusion
      The doublets carboplatin and gemcitabine could be a valuable treatment option in elderly Thai patients. The activity and safety observed in this report is within the range of data reported for doublet chemotherapy regimen in the elderly patient with NSCLC.

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      P3.24-035 - Evaluating health related quality of life and symptoms by using the electronic (ePRO) version of the LCSS (eLCSS-QL) in a 622 patient prospective multinational NSCLC trial (AP-QL Trial) with good cross-cultural reliability. (ID 2397)

      09:30 - 09:30  |  Author(s): S. Thongprasert

      • Abstract

      Background
      Major goals in advanced NSCLC include accurate evaluation of survival and quality of life. Few trials evaluate both of these major endpoints well. In many studies, only a minority of patients have quality of life and other patient reported outcomes (PROs) such as symptoms systematically followed over time, which decreases the value of the assessment of the treatment. Prior studies have identified barriers to measuring quality of life in clinical trials and in practice. To overcome these barriers, we used a computer-assisted version of the validated LCSS measure and tested this prospectively in a large study in patients with Stage IV and IIIB NSCLC. The eLCSS-QL requires only two minutes for completion of the patient version and proved to be highly acceptable in earlier studies (Hollen, Supp Care Cancer 2012).

      Methods
      This trial was conducted at 65 sites in 9 Asian countries. 622 patients received first-line treatment with docetaxel -based chemotherapy. Patient demographics included: 70% male; 65% adenocarcinoma; median: KPS = 90; ECOG = 1 (27% ECOG 0). Stages: IV (72%), IIIB (28%). 84% had two or more major symptoms. 80% received combination chemotherapy with cisplatin (52%) or carboplatin (28%). The eLCSS-QL was completed every 3 weeks at the clinic. We also surveyed 98 physicians and nurses treating these patients regarding their experiences concerning communication, usefulness and acceptability of the eLCSS-QL.

      Results
      Ninety-seven percent of patients completed the eLCSS-QL at baseline; 90% completed follow-up evaluations. Over 90% found the eLCSS-QL easy to use and acceptable to complete at each visit. More than 80% of patients reported increased awareness of symptoms and that the quality of life evaluation made it easier to speak with doctors and nurses. 1% refused eLCSS-QL completion. Of physicians and nurses, more than 90% found the eLCSS-QL easy to use and increased symptom awareness; 80% reported improved communication, enhanced satisfaction with the patient visit, and would recommend its use to others. Nearly 90% of physicians reported they could identify benefit from chemotherapy earlier; 76% would order fewer imaging tests and 80% said the eLCSS-QL could save time. Cross-cultural testing was performed in this 9 nation trial. Cronbach’s alpha scores were high for each country, and exceeded 0.85 overall, demonstrating good cross-cultural reliability. Treatment outcomes: major response rate 37%; median survivals: 13.9 months (docetaxel + cisplatin), 12.7 months (docetaxel + carboplatin).

      Conclusion
      Placing the well validated LCSS onto an electronic platform (eLCSS-QL) helped overcome barriers to evaluating QL in this large clinical trial, with 90% of patients completing baseline and repeated QL measures. Patients, physicians, and nurses all found the eLCSS-QL to be highly acceptable and easy to use. The good cross-cultural aspects of the eLCSS-QL indicate that the electronic platform is particularly suitable for multinational trials. This large prospective trial demonstrates that improved compliance with quality of life and PRO evaluation is feasible and can easily be accomplished in large clinical trials. Additionally, the electronic format enhances the potential for the use of PROs in decision making in clinical practice.