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O21 - SCLC II (ID 119)
- Event: WCLC 2013
- Type: Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
O21.02 - Phase III trial comparing irinotecan plus cisplatin (IP) with etoposide plus cisplatin (EP) in Korean patients with extensive disease (ED) small cell lung cancer (SCLC) (ID 2937)
16:15 - 17:45 | Author(s): S.W. Shin
IP showed superior survival outcomes compared with EP in Japanese patients. However, IP failed to show the superiority in subsequent studies in Western population. We conducted a multi-center randomized controlled trial to determine whether IP regimen is superior to EP regimen in Korean patients (ClinicalTrials.gov Identifier: NCT00349492)
Patients were randomly assigned (simple randomization, stratified by ECOG performance status and center) to IP (irinotecan 65 mg/m2 IV on D1&8 plus cisplatin 70 mg/m2 IV on D1, every 3 weeks) or EP (etoposide 100 mg/m2 IV on D1-3 plus cisplatin 70 mg/m2 IV on D1, every 3 weeks) for maximum 6 cycles, until disease progression, or until unacceptable toxicity occurred. The primary objective was to compare overall survival (OS).
A total of 362 patients were randomized to IP (N=173) and EP (N=189) arms. Median OS was 10.9 and 10.3 months (m) for IP and EP, respectively (hazard ratio for death in the IP group, 0.879; 95% one-sided confidence interval, 0 to 1.054; P=0.1207). Objective response rate was higher with IP than with EP (62.4%, 48.2%, P=0.0064), however, there was no significant difference in median progression free survival between IP and EP (6.5 and 5.8 m, P=0.1158). In the pre-planned subgroup analyses, IP was associated with longer OS than with EP in male (11.3 vs 10.1 m, P=0.0361), <65 years old (12.7 vs 11.3 m, P=0.0240), ECOG performance status 0/1 (12.4 vs 10.9 m, P=0.0407) patients group. Grade 3/4 anemia, nausea and diarrhea were more frequent in patients treated with IP. There was no difference in the frequency of grade 3/4 neutropenia, thrombocytopenia, neutropenic fever, infection between both arms.
IP failed to show superiority in overall survival compared to EP in Korean patients with ED SCLC. However, prolongation of OS was observed with IP in pre-defined subgroup of patients with male gender, young age, or good performance status.
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P1.24 - Poster Session 1 - Clinical Care (ID 146)
- Event: WCLC 2013
- Type: Poster Session
- Track: Supportive Care
- Presentations: 1
- Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level
P1.24-023 - Envoy Service, a form of dignity therapy, designed to assist communication and palliative care decision for patients with advanced cancer: a preliminary report. (ID 1765)
09:30 - 16:30 | Author(s): S.W. Shin
Patients with advanced cancer experience various difficulties to communicate and express regarding their wishes, personal values and end-of-life care options. These difficulties could be serious obstacles to initiate early palliative care decision and consequently lead to unwanted and/or futile invasive end-of- life care. There is an urgent need to develop innovative approach to address suffering and distress and improve communication between patients and family members, care givers’ and medical providers.
“Envoy Service” was designed to assist patients' own words delivered to family members, friends, care givers in processed and edited form. The assigned patients were interviewed by trained dialogist (2 nurses and 3 clinical psychologists), in individualized and narrative style for 30 to 60 minutes per session up to 3 sessions. During the interview, pre-structured questioned regarding palliative care and end-of-life care options. Additionally, patients are offered to speak what matters most to them, things they would most want remembered. The whole interview process could be videotaped, or voice recorded, or writes down by the dialogist, or in combination upon the patients’ own choices. Once interview sessions completed, the dialogues were reshaped into narrative form and carefully edited in the form of video-audio clip recorded in CDs, or letters. The final products were returned to patients to bequeath to a friend or family member. The responses of patients and family members and caregivers’ and medical provider’s opinions were collected and examined.
Twelve patients with advanced cancer (age 40-68, median 57, 5 female, 7 male, 4 lung cancer, 2 head and neck cancer, 5 GI cancer, 1 Gy cancer) received “Envoy service”. It was offered in two hospitals; five patients in Korea University Medical Centre (university Hospital) and seven patients in Seoul Medical Centre (General Hospital) respectively. Interview with dialogist took usually 30-60 minutes (median 40 min) in each session and 1-3 (median 1) sessions. All twelve patients expressed their emotional feeling regarding their illness, fear of death and dying, briefly reviewed their own lives and personal appreciation to their family members and medical providers. Regarding the end-of-life care options, 6 patients choose non-invasive care and 3 patients wished to be chosen by their care giver and physician’s discretion, 3 patients did not evidently spoke about. The edited products, 1 CD, 11 letters were returned to patients to bequeathed to family members. Seven patients reported feeling satisfied. Five patients indicated that the service heightened their physical and psychological well-being. One dialogist reported that completion of services, patients were looked “ready” for dignified end-of-life. Four patients died, 3 without any invasive care, but 1 in ICU.
"Envoy service” a form of dignity therapy, is feasible and could be a novel approach to address distress and suffering of patients with advanced cancer. It might help patients to communicate with family members and caregivers and leads to initiate early palliative care and avoid unnecessary invasive procedure near end-of-life.