- Email: [email protected]
Management and clinical outcome in elderly patients with gynecologic malignancies: single institutional experience
9th SIOG Meeting, October 16–18, 2008, Montreal, Canada: Posters
S51
P.65 Information needs of adults patients with newly diagnosed acute myeloid leukaemia (AML)
Results: Twenty-one patients with primary gynecologic malignancies were initially treated with surgery (n = 13) with/without adjuvant chemoradiation (n = 2) and radiotherapy (n = 3), concurrent chemoradiation (n = 3) or palliative radiotherapy (n = 2) or chemotherapy (n = 2) and only supportive care (n = 1), in contrast to all of recurrent diseases (n = 8) with palliative salvage chemotherapy. Through pretreatment assessment, depressive mood was newly diagnosed in three patients and cognitive dysfunction in one patient. Significant treatment toxicity were frequently seen in the initial or adjuvant chemotherapy (about 50%), the most common being neutropenia ((mucositis (n = 2), diarrhea, nephrotoxicity, and neurotoxicity (each one patient). Excluding patients with no follow-up data for treatment response (n = 2) or immediate postoperative (n = 2) or ongoing treatment state, there were two deaths and two progression of disease even though cancer treatment, whose functional status was rapidly worsened. Patients showing no evidence of disease were in their good functional or performance status. Conclusion: Our data indicate that modern chemotherapy and other management are feasible to the relatively fit elderly patients and control disease in a manner comparable to younger patients. Decline of functional status, even though clearly show in elderly patients, may be caused by disease progression, not by age itself. Therefore, the elderly patients need close observation and delicate supportive management for symptom control.
H.Z. Mohamedali *, H. Breunis, M. Minden, S.M.H. Alibhai. Princess Margaret Hospital/University Health Network, University of Toronto, Toronto, Canada Background and Objectives: AML is a common haematological cancer, particularly affecting older adults. The overall prognosis is poor, with a median survival of less than 1 year, and treatment decisions must often be made quickly after diagnosis. As such, patients often feel overwhelmed at making treatment decisions. At present, there is no published research examining how decision-making issues impact patient satisfaction and decisional regret in this population. This pilot study was designed to investigate the decision-making process among newly diagnosed AML patients. In addition, this study aimed to explore how age and other decision-making factors at the time of diagnosis impacted subsequent satisfaction and regret. Methods: English-speaking AML patients age 18 or older who were seen at a tertiary cancer centre either at diagnosis, one month after diagnosis or 5−6 months after diagnosis were approached between May and July 2008. For patients that were approached at the time of diagnosis, a one-month follow-up visit was also scheduled. Patients were given selfadministered questionnaires at each visit, which included the Satisfaction with Decision (SWD) scale, the Decisional Regret Scale (DRS), the Control Preferences Scale (CPS), the Beck Depression Inventory (BDI), as well as fatigue, quality of life and social support questions. Analyses are primarily descriptive at present. Results: To date, 21 patients (age 26–83 years, 11 female) have been recruited; 52% were older patients (>60 years). Overall, most patients were satisfied with their treatment decision and levels of decisional regret were low. Patients interviewed at diagnosis reported a high level of trust in their physician and felt that the time spent by the physician with them was just right. Based on the CPS, all of the patients felt that the role they preferred was the role they actually played in their treatment decision. Decisional regret appeared to increase over time, with a mean score of 5 in patients interviewed one month after diagnosis, and a mean score of 8.7 in patients interviewed at the 5–6 month time point. In general, most patients perceived a high level of support from family and friends. However, younger patients felt that their family and friends played a greater role in their decision-making than older patients. Furthermore, 71% of younger patients were classified as having at least mild depression according to the BDI, compared to 40% of older patients. Conclusions: The majority of newly diagnosed AML patients were satisfied with their treatment decision, had low levels of decisional regret and high levels of social support. All of the patients reported concordance between preferred and actual role in decision-making. Younger patients appear to receive more family input in their treatment decision-making, but younger patients also reported higher levels of depressive symptoms. Further recruitment is ongoing to confirm these preliminary findings and updated results will be presented. P.66 Management and clinical outcome in elderly patients with gynecologic malignancies: single institutional experience J.W. Kim *, M.J. Kim, H.H. Chung, N.H. Park, Y.S. Song, S.B. Kang. Department of Obstetrics and Gynecology, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea Objective: To analyze clinical data on elderly patients with gynecologic malignancies and to identify the predictors of clinical benefit from treatment. Materials and Methods: Twenty-nine patients aged 70 years (median age of 70, range from 70 to 88) who were diagnosed with primary or recurrent gynecologic malignancies of cervix, ovary, endometrium, vulva or other genital tracts and then managed in our institute were evaluated with Korean-validated geriatric assessment before initial treatment. Including electric medical data, all data of demographic and physical status from geriatric assessment were evaluated.
Session XII P.67 Evaluation of investigational drugs in geriatric patients: are geriatric specific trials necessary? G. Sokol1 *, L. Loftus1 , J. Knudsen2 , L. Cantilena3 , R. Kane2 . 1 H Lee Moffitt Cancer Center, Tampa, Florida, 2 Center for Drug Evaluation Research, FDA, Silver Spring, MD, 3 Uniformed Services University, Bethesda, MD, USA Introduction: The US population is aging. The median age of subjects with a cancer diagnosis is 67, and the median age of all cancer deaths is 73. The 1989 FDA Guidance for study of drugs recommended inclusion of elderly patients to define efficacy and safety in confirmatory studies. ICH E7 - Studies in Elderly 1994 specified that patients entering clinical trials should be representative of the population to be treated. Arbitrary age cutoffs should be avoided, and Phase 3 trials should include at least 100 patients > age 65. Separate studies are an option, but inclusion of geriatric patients in the same trial allows direct comparison of safety, efficacy, and dose-response differences between age groups. FDA initiatives have included NDA data − sponsor analysis by age required in 1997, age-related labeling issues, and reviewer guidance on conducting efficacy and safety analyses by age 65 in trials. The current NDA model does not address the unique circumstances of organ function, performance status, defined therapy, and potential age-related biological differences for a substantial proportion of geriatric patients. Methods: Medline, Google, Medscape and Pubmed reviews were initiated to explore unique issues of geriatric oncology germane to potential items of regulatory interest. The review yielded a multitude of regulatory issues pertaining to geriatric oncology. Results: Age-specific survival differences between younger and older trial subjects with leukemia, multiple myeloma, breast, lung, and brain tumors were observed. There are PK /PD and relative toxicity issues pertinent to clinical trial evaluation. Unique inherent tumor differences in molecular composition and signal transduction pathways between older and younger study patients have also been reported. The risk reward benefits and therapeutic ratios differ between older and younger individuals making clinical benefit analysis problematic. Multiple ethical issues arise concerning allocation of limited resources and costly pharmaceutical agents of borderline efficacy in subjects with limited life spans. Discussion: Due to the special regulatory issues relevant to the geriatric population, a trial design specific to this cohort should be considered for a multitude of reasons. Older subjects as a rule sustain higher morbidity and mortality from clinical trials unless they are carefully screened for performance status and acceptable absence of significant co-morbidity. Targeted agents affecting angiogenesis have different efficacy in younger
S51
P.65 Information needs of adults patients with newly diagnosed acute myeloid leukaemia (AML)
Results: Twenty-one patients with primary gynecologic malignancies were initially treated with surgery (n = 13) with/without adjuvant chemoradiation (n = 2) and radiotherapy (n = 3), concurrent chemoradiation (n = 3) or palliative radiotherapy (n = 2) or chemotherapy (n = 2) and only supportive care (n = 1), in contrast to all of recurrent diseases (n = 8) with palliative salvage chemotherapy. Through pretreatment assessment, depressive mood was newly diagnosed in three patients and cognitive dysfunction in one patient. Significant treatment toxicity were frequently seen in the initial or adjuvant chemotherapy (about 50%), the most common being neutropenia ((mucositis (n = 2), diarrhea, nephrotoxicity, and neurotoxicity (each one patient). Excluding patients with no follow-up data for treatment response (n = 2) or immediate postoperative (n = 2) or ongoing treatment state, there were two deaths and two progression of disease even though cancer treatment, whose functional status was rapidly worsened. Patients showing no evidence of disease were in their good functional or performance status. Conclusion: Our data indicate that modern chemotherapy and other management are feasible to the relatively fit elderly patients and control disease in a manner comparable to younger patients. Decline of functional status, even though clearly show in elderly patients, may be caused by disease progression, not by age itself. Therefore, the elderly patients need close observation and delicate supportive management for symptom control.
H.Z. Mohamedali *, H. Breunis, M. Minden, S.M.H. Alibhai. Princess Margaret Hospital/University Health Network, University of Toronto, Toronto, Canada Background and Objectives: AML is a common haematological cancer, particularly affecting older adults. The overall prognosis is poor, with a median survival of less than 1 year, and treatment decisions must often be made quickly after diagnosis. As such, patients often feel overwhelmed at making treatment decisions. At present, there is no published research examining how decision-making issues impact patient satisfaction and decisional regret in this population. This pilot study was designed to investigate the decision-making process among newly diagnosed AML patients. In addition, this study aimed to explore how age and other decision-making factors at the time of diagnosis impacted subsequent satisfaction and regret. Methods: English-speaking AML patients age 18 or older who were seen at a tertiary cancer centre either at diagnosis, one month after diagnosis or 5−6 months after diagnosis were approached between May and July 2008. For patients that were approached at the time of diagnosis, a one-month follow-up visit was also scheduled. Patients were given selfadministered questionnaires at each visit, which included the Satisfaction with Decision (SWD) scale, the Decisional Regret Scale (DRS), the Control Preferences Scale (CPS), the Beck Depression Inventory (BDI), as well as fatigue, quality of life and social support questions. Analyses are primarily descriptive at present. Results: To date, 21 patients (age 26–83 years, 11 female) have been recruited; 52% were older patients (>60 years). Overall, most patients were satisfied with their treatment decision and levels of decisional regret were low. Patients interviewed at diagnosis reported a high level of trust in their physician and felt that the time spent by the physician with them was just right. Based on the CPS, all of the patients felt that the role they preferred was the role they actually played in their treatment decision. Decisional regret appeared to increase over time, with a mean score of 5 in patients interviewed one month after diagnosis, and a mean score of 8.7 in patients interviewed at the 5–6 month time point. In general, most patients perceived a high level of support from family and friends. However, younger patients felt that their family and friends played a greater role in their decision-making than older patients. Furthermore, 71% of younger patients were classified as having at least mild depression according to the BDI, compared to 40% of older patients. Conclusions: The majority of newly diagnosed AML patients were satisfied with their treatment decision, had low levels of decisional regret and high levels of social support. All of the patients reported concordance between preferred and actual role in decision-making. Younger patients appear to receive more family input in their treatment decision-making, but younger patients also reported higher levels of depressive symptoms. Further recruitment is ongoing to confirm these preliminary findings and updated results will be presented. P.66 Management and clinical outcome in elderly patients with gynecologic malignancies: single institutional experience J.W. Kim *, M.J. Kim, H.H. Chung, N.H. Park, Y.S. Song, S.B. Kang. Department of Obstetrics and Gynecology, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea Objective: To analyze clinical data on elderly patients with gynecologic malignancies and to identify the predictors of clinical benefit from treatment. Materials and Methods: Twenty-nine patients aged 70 years (median age of 70, range from 70 to 88) who were diagnosed with primary or recurrent gynecologic malignancies of cervix, ovary, endometrium, vulva or other genital tracts and then managed in our institute were evaluated with Korean-validated geriatric assessment before initial treatment. Including electric medical data, all data of demographic and physical status from geriatric assessment were evaluated.
Session XII P.67 Evaluation of investigational drugs in geriatric patients: are geriatric specific trials necessary? G. Sokol1 *, L. Loftus1 , J. Knudsen2 , L. Cantilena3 , R. Kane2 . 1 H Lee Moffitt Cancer Center, Tampa, Florida, 2 Center for Drug Evaluation Research, FDA, Silver Spring, MD, 3 Uniformed Services University, Bethesda, MD, USA Introduction: The US population is aging. The median age of subjects with a cancer diagnosis is 67, and the median age of all cancer deaths is 73. The 1989 FDA Guidance for study of drugs recommended inclusion of elderly patients to define efficacy and safety in confirmatory studies. ICH E7 - Studies in Elderly 1994 specified that patients entering clinical trials should be representative of the population to be treated. Arbitrary age cutoffs should be avoided, and Phase 3 trials should include at least 100 patients > age 65. Separate studies are an option, but inclusion of geriatric patients in the same trial allows direct comparison of safety, efficacy, and dose-response differences between age groups. FDA initiatives have included NDA data − sponsor analysis by age required in 1997, age-related labeling issues, and reviewer guidance on conducting efficacy and safety analyses by age 65 in trials. The current NDA model does not address the unique circumstances of organ function, performance status, defined therapy, and potential age-related biological differences for a substantial proportion of geriatric patients. Methods: Medline, Google, Medscape and Pubmed reviews were initiated to explore unique issues of geriatric oncology germane to potential items of regulatory interest. The review yielded a multitude of regulatory issues pertaining to geriatric oncology. Results: Age-specific survival differences between younger and older trial subjects with leukemia, multiple myeloma, breast, lung, and brain tumors were observed. There are PK /PD and relative toxicity issues pertinent to clinical trial evaluation. Unique inherent tumor differences in molecular composition and signal transduction pathways between older and younger study patients have also been reported. The risk reward benefits and therapeutic ratios differ between older and younger individuals making clinical benefit analysis problematic. Multiple ethical issues arise concerning allocation of limited resources and costly pharmaceutical agents of borderline efficacy in subjects with limited life spans. Discussion: Due to the special regulatory issues relevant to the geriatric population, a trial design specific to this cohort should be considered for a multitude of reasons. Older subjects as a rule sustain higher morbidity and mortality from clinical trials unless they are carefully screened for performance status and acceptable absence of significant co-morbidity. Targeted agents affecting angiogenesis have different efficacy in younger