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Hiroaki Okamoto
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MA 17 - Locally Advanced NSCLC (ID 671)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:S. Jheon, Georgios Stamatis
- Coordinates: 10/17/2017, 15:45 - 17:30, F203 + F204 (Annex Hall)
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MA 17.06 - Safety Data from Randomized Phase II Study of CDDP+S-1 vs CDDP+PEM Combined with TRT for Locally Advanced Non-Squamous NSCLC (ID 8296)
16:20 - 16:25 | Author(s): Hiroaki Okamoto
- Abstract
- Presentation
Background:
Both cisplatin (CDDP)+S-1 and CDDP+pemetrexed (PEM) can be given at full systemic doses with thoracic radiotherapy (TRT) in locally advanced non-small cell lung cancer (NSCLC), and CDDP+PEM is one of the standard chemotherapy regimens in patients with advanced non-squamous (non-sq) NSCLC. This multicenter, randomized, open-label, phase II study (SPECTRA) compared the efficacy and safety of the two above-mentioned promising regimens combined with TRT in patients with unresectable locally advanced non-sq NSCLC.
Method:
Patients were randomly assigned to receive CDDP+S-1 (CDDP 60mg/m2, d1, and S-1 80mg/m2, d1-14, q4w, up to 4 cycles) or CDDP+PEM (CDDP 75mg/m2, d1, and PEM 500mg/m2, d1, q3w, up to 4 cycles) combined with TRT 60Gy in 30 fractions. The primary endpoint was 2-year progression-free survival (PFS) rate. If the 2-year PFS rate is assumed to be 25% in the inferior therapy group and 15% higher in the superior therapy group of this study, the sample size needed for selection of the optimum treatment group at a probability of approximately 95% will be 51 cases/group with the Simon’s selection design. The sample size was set at 100 patients.
Result:
Between Jan 2013 and Oct 2016, 102 patients were enrolled in this study from 9 institutions in Japan. All 102 patients were eligible and assessable, of whom 52 were assigned to CDDP+S-1 and 50 to CDDP+PEM. Baseline characteristics were similar (CDDP+S-1/CDDP+PEM): median age (range) 64.5 (39-73)/63.5 (32-74) years; women, n=17 (33%)/n=17 (34%); stage IIIB, n=21 (40%)/n=20 (40%); ECOG PS of 1, n=14 (27%)/n=14 (28%); never smoker, n=12 (23%)/n=12 (24%); and adenocarcinoma, n=47(90%)/n=45(90%). Completion rate of TRT (60Gy) and chemotherapy (4 cycles) was 92%/98% and 73%/86%, respectively. Response rate was 60%/64%. Grade 3 or higher toxicities included febrile neutropenia (12%/2%), anorexia (8%/16%), diarrhea (8%/0%), esophagitis (6%/8%), pneumonia (4%/4%), neutropenia (38%/52%), anemia (8%/12%), thrombocytopenia (4%/6%), and hyponatremia (12%/12%). Grade 1 radiation pneumonitis was observed in 8 (15%)/2 (4%) patients on the basis of the data collected 30 days or less after the discontinuation of protocol treatment. No treatment-related death was observed. The data on PFS and overall survival are immature.
Conclusion:
Response rate was similar between the two arms. Toxicities were tolerable and manageable in both arms; however febrile neutropenia was more frequently observed in the CDDP+S-1 arm. We will present the updated safety data of this study at the conference. Survival data will be analyzed in late 2018.
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MS 20 - Value-based Management for Special Populations (ID 542)
- Event: WCLC 2017
- Type: Mini Symposium
- Track: Nursing/Palliative Care/Ethics
- Presentations: 1
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MS 20.03 - What Do Patients Want at the End of Life? - East vs West (ID 7739)
11:40 - 12:00 | Presenting Author(s): Hiroaki Okamoto
- Abstract
- Presentation
Abstract:
Although advance care planning (ACP) may prevent non-beneficial care that is discordant with patient wishes at the end-of-life (EOL), nearly 40% of bereaved families in the US said their loved ones had not discussed their EOL care preferences with them (Narang et al, JAMA Oncol 2015). Fewer Japanese studies on EOL discussions (EOLd) with patients have been reported than studies in Western countries. Similarly, few studies investigating what patients want at the EOL have been reported in Japan. Most Japanese studies related to EOL have focused on medical staff, bereaved families, or healthy persons in the general population, rather than on patients themselves. In addition, the most common method of data collection for these studies in Japan has been through administration of questionnaire surveys by mail (J-HOPE3 study 2016, in Japanese). While the perspectives of care providers and family may indirectly reflect the preferences of patients, previous studies have not assessed cancer patients directly and therefore knowledge regarding EOL preferences for this population remains limited and unclear. Possible reasons for not directly investigating the EOL preferences of cancer patients may be related to Japanese cultural taboos regarding discussion of death with cancer patients and the positive cultural value of living without awareness of death, even in the terminal stage of disease. These factors lead to reluctance in discussing EOL care among patients, family members, and medical staff. In contrast, 70% of cancer patients in Sweden had discussions about death with family members within 3 months of their death (Jonasson et al, Eur J Cancer 2011). In a previous study of 529 Japanese cancer patients, only half of the patients preferred to receive information regarding their life expectancy and 30% preferred not to receive such information. Furthermore, 90% of the patients preferred to have their physicians consider the feelings of their family as well (Fujimori et al, Psychooncology 2007). One Japanese research study on the hopes of terminally-ill patients found that symptom control was the most frequently expressed hope at the time of admission to a palliative care unit (PCU). However, patient hopes regarding symptom control and recovery decreased as death approached. In contrast, both existential hope and hope of good human relations increased by the time of death (Naka et al, Shi no rinsho 1998, in Japanese). EOLd should repeatedly occur among patients, families, and medical staff, before patients become incompetent, because patient preferences may change in unexpected ways, as was found in a study of advanced lung cancer patients (Pardon et al, Support Care Cancer 2012). Another Japanese study of advanced cancer patients found that patients strongly preferred that their physicians listen to their distress and concerns (96%), assure them that their painful symptoms would be controlled (97%), and explain the status of their illness and the physical symptoms that would likely occur in the future (95%) (Umezawa et al, Cancer 2015). Patient preferences or hopes near the EOL appear to be similar between Western and Japanese cultures. However, fewer Japanese studies on EOLd have been reported because of cultural taboo for talking about death. In our hospital, when patients with advanced lung cancer had an initial consultation with palliative care physicians to prepare for future PCU admission (N=46), the reasons expressed by patients or their families for considering PCU admission were “want to reduce pain (70%)”, “want to reduce distress (59%)”, “want to live without intensive life-sustaining care (52%)”, and “recommendation by attending physicians or caregivers (39%)”. However, only 9% of patients clearly understood their life expectancy when considering PCU admission. Interestingly, many terminally-ill Japanese cancer patients may wish to take a bath before death. For example, 40% of patients with advanced cancer were bathed while receiving home nursing services within 4 days of death (Tanabe et al, Hospice and Home Care 2015, in Japanese). The role of rehabilitation in PCUs remains unclear and one study found that only 20% of terminally ill cancer patients received rehabilitation in Japan. However, the rate of satisfaction for the rehabilitation reported by bereaved families was extremely high (80%) (J-HOPE3 study 2016, in Japanese). There is limited published information about how physicians obtain the skills necessary for managing their own discomfort with talking about death. Communicating in an honest manner, without taking away hope, is an essential skill for the physician treating terminally-ill cancer patients. Japanese physicians, however, are less likely to have educational opportunities to learn how to discuss bad news with patients. Japanese physicians, in particular, often feel discomfort with discussing prognosis, hospice, site of death, and do-not-resuscitate (DNR) status with patients. Improvement in the communication skills of physicians is key to facilitating more appropriate ACP with cancer patients. For communication with terminally-ill cancer patients, the classic strategy of “hope for the best and prepare for the worst” or “use more open questions rather than closed questions with patients” can be recommended as part of an ACP discussion. Using a palliative prognostic index may be helpful in predicting prognosis for terminally-ill cancer patients more accurately (Maltoni et al, Oncologist 2012). However, because accurate prognostic understanding has been found to be associated with lower quality of life (QOL) and worse anxiety, these patients should be offered psychosocial support (El-Jawahri, Cancer 2014). Discordance between the care desired and the care received by patients is another important EOL issue. The use of structured communication tools, rather than an ad-hoc approach, is recommended to facilitate more appropriate EOLd, and to avoid care not desired by patients (Oczkowski et al, PLoS One 2016). Finally, a phase III study evaluating the role of early palliative care (EPC) suggested that EPC provided significantly better QOL and better survival than usual care in patients with advanced non-small cell lung cancer (Temel et al, N Engl J Med 2010). Similarly, our feasibility study demonstrated that EPC provided better QOL in patients with advanced lung cancer (Yokoyama et al. WCLC 2015). We recommend EPC referrals for lung cancer patients to support earlier EOLd and earlier understanding of the hopes and goals of patients with advanced lung cancer.
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P2.07 - Immunology and Immunotherapy (ID 708)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.07-042 - Feasibility Study of Nivolumab and Docetaxel in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer (ID 9936)
09:30 - 09:30 | Author(s): Hiroaki Okamoto
- Abstract
Background:
Nivolumab (NIV) is a standard second-line treatment for previously treated patients with advanced non-small cell lung cancer (NSCLC). Although there is a possibility that a higher effect can be expected by combination NIV and cytotoxic agents, verification in a clinical trial is required. Because there was only one report of phase Ib trial (N=6) of NIV + docetaxel (DTX) combination (Kanda et al, Ann Oncol 2016), we planned a feasibility study to examine the safety of this combination prior to large scale clinical trials.
Method:
Eligibility criteria included a history of platinum-based chemotherapy, PS 0-1, and adequate organ functions. Patients received NIV 3 mg/kg (days 1, 15) and DTX 60mg/m[2 ](day 1) every 4 weeks for a maximum of 2 courses. The primary endpoint was safety of 1st course and evaluated dose-limiting toxicities (DLT). This study used a 3 + 3 design and was considered to be feasible if DLT occurred in one-thirds or less of the patients. The secondary endpoints were the adverse events and the response rate. DLT was defined in accordance with the phase Ib study of Kanda et al .
Result:
Between Aug 2016 and Sep 2016, three patients were enrolled into this trial in 2 centers in Japan. First case was 57 years old female / adenocarcinoma, 2nd case was 44 years old male / squamous cell carcinoma, 3rd case was 58 years old male / adenocarcinoma. Grade 3 or more adverse events occurred only in one case of Grade 4 neutropenia, and no DLTs were observed in any cases. All patients completed 2 courses and objective tumor responses were PD, SD, PR, respectively. Two of three patients still survive more than 10 months from start of this therapy.
Conclusion:
NIV+ DTX combination therapy was acceptable for safety and further evaluation is warranted. Because the use of combination NIV plus cytotoxic agents is not approved in Japan, we are planning to conduct a phase II / III trial (CONDUCT study) comparing NIV + DTX with NIV alone in previously treated patients with advanced NSCLC in the Thoracic Oncology Research Group (TORG), using an Advanced Medical Healthcare in Japan.
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P2.15 - SCLC/Neuroendocrine Tumors (ID 716)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.15-004 - Underrepresentation of Elderly Patients with ED-SCLC as Clinical Trial Candidates (JCOG1201/TORG1528) (ID 8837)
09:30 - 09:30 | Author(s): Hiroaki Okamoto
- Abstract
Background:
Since December 2013, we initiated a phase II/III trial [Japan Clinical Oncology Group (JCOG) 1201/Thoracic Oncology Research Group (TORG) 1528: UMIN000012605] for elderly patients with extensive-disease small-cell lung cancer (ED-SCLC). Aim of the study is to demonstrate that a carboplatin plus irinotecan regimen is superior to carboplatin plus etoposide in elderly patients with ED-SCLC. However, the patient accrual rate did not satisfactorily match our expectations a year from the time of initiation of our study. To define factors related to low accrual, we searched institutional records and analyzed.
Method:
We collected data of elderly patients with ED-SCLC from each institution and investigated the total number of elderly patients with ED-SCLC, number of patients eligible/ineligible for the study, numbers of patients registered for the study, and the reasons for non-registration of even eligible patients. Doctor-reported questionnaires concerning elderly (≥71 years old) ED-SCLC patients diagnosed in their institutions were sent to chief or coordinate doctors at each institution in December 2014.
Result:
We received a response from 32 (84%) of 38 institutions. Approximately 260 patients were diagnosed as elderly patients with ED-SCLC in the last year. Only 100 patients (38%) were eligible for the JCOG 1201/TORG1528 trial. Reasons for ineligibility primarily included poor performance status (PS) (25%), low organ functions (25%), interstitial pneumonitis (19%) and double cancer (18%). Only 23 patients among the 100 eligible candidates accrued to the study. The primary reasons for non-accrual were delayed approval from the Institutional Review Board (IRB) of the individual institution (24%), physician preferences (23%), patient refusal (18%), and registration for other trials (12%).
Conclusion:
Our data demonstrated that 62% of ED-SCLC patients were ineligible for the protocol due to frailty with the most frequent reason being comorbidities such as poor PS and low organ functions. However, inactive institutions need to increase their efforts to register a greater number of eligible patients in addition to obtaining quicker IRB approval of protocol. Based on responses to questionnaires sent out as part of our investigation, in January 2016, the protocol was revised in terms of eligibility criteria to enhance patient accrual. Eligibility criteria for participation of elderly patients with ED-SCLC need to be formulated prudently so that patients are benefitted in routine clinical practice.
