- Email: [email protected]
1581 Biosimilar filgrastim treatment patterns and prevention of febrile neutropenia: A multicentric observational national French study in patients with solid tumors (The Zohé study)
Abstracts Kansai Clinical Oncology Group (KCOG) conducted two prospective phase II multicenter trials to investigate efficacy of antiemetic therapy in gynecological cancer patients receiving highly-emetogenic chemotherapy (HEC) that included cisplatin (50 mg/m2 ). KCOG-G1003 investigated efficacy of standard triplet therapy and KCOG-G1301 investigated efficacy of olanzapine combined with triplet therapy for preventing CINV induced by HEC. We compared these outcomes of two trials. Material and Methods: KCOG-G1003 and KCOG-G1301 were conducted using almost the same protocols and 96 and 40 gynecological cancer patients receiving HEC with cisplatin were enrolled, respectively. In KCOGG1003, palonosetron, aprepitant, and dexamethasone were administered as standard antiemetic triplet therapy. In KCOG-G1301, olanzapine (5 mg) was administered with triplet therapy a day prior to cisplatin administration and on days 1−5. In both trials, all patients recorded their emesis in the self-evaluation symptom diary every 24 h, for 120 h after cisplatin administration. The primary endpoint was complete response (CR; no vomiting and no rescue) rate in the overall phase (0–120 h postchemotherapy). The secondary endpoints were CR rates in the acute phase (0−24 h post-chemotherapy) and delayed phase (24–120 h postchemotherapy), as well as complete control (CC; no vomiting, no rescue, and no significant nausea) rate and total control (TC; no vomiting, no rescue, and no nausea) rate. These endpoints were evaluated during the first cycle of chemotherapy. Results: In KCOG-G1003, CR rates for overall, acute, and delayed phases were 54.2%, 87.5%, and 56.3%, respectively. CC rates for overall, acute, and delayed phases were 44.8%, 82.3% and 45.8%, respectively. TC rates for overall, acute, and delayed phases were 27.1%, 69.8% and 29.2%, respectively. In KCOG-G1301, CR rates for overall, acute, and delayed phases were 92.5%, 97.5%, and 95.0%, respectively. CC rates for overall, acute, and delayed phases were 82.5%, 92.5% and 87.5%, respectively. TC rates for acute, delayed, and overall phases were 87.5%, 67.5%, and 67.5%, respectively. There ware no grade 3 or 4 adverse events. Conclusions: Preventive use of olanzapine with triplet therapy gives better results than those from triplet therapy. The results of the two trials cannot be simply compared. However, because both trials were conducted using almost the same protocols, we assume that a four-agent regimen containing olanzapine will have a higher therapeutic effect. It is suggested that preventive use of olanzapine combined with triplet therapy could be useful antiemetic regimen in the prevention of CINV induced by HEC. No conflict of interest. 1580 POSTER Influence of ABCB1 and ABCG2 polymorphisms on the antiemetic efficacy of a triple antiemetic combination in cancer patients receiving cisplatin-based chemotherapy: TRIPLE Pharmacogenomics Study K. Suzuki1 , D. Tsuji2 , M. Yokoi3 , T. Daimon4 , M. Nakao5 , H. Ayuhara6 , Y. Kogure7 , K. Shibata8 , T. Hayashi9 , K. Takeda10 , M. Nishio11 , T. Hama12 , K. Itoh3 . 1 The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Department of Pharmacy, Tokyo, Japan; 2 University of Shizuoka, School of Pharmaceutical Sciences, Sizuoka, Japan; 3 University of Shizuoka, School of Pharmaceutical Sciences, Shizuoka, Japan; 4 Hyogo College of Medicine, Department of Biostatistics, Nishinomiya, Japan; 5 Osaka City General Hospital, Department of Pharmacy, Osaka, Japan; 6 Tokyo Medical University Hospital, Department of Pharmacy, Tokyo, Japan; 7 National Hospital Organization Shikoku Cancer Center, Department of Pharmacy, Matsuyama, Japan; 8 Koseiren Takaoka Hospital, Department of Medical Oncology, Takaoka, Japan; 9 National Hospital Organization, Department of Pharmacy, Fukuoka, Japan; 10 Osaka City General Hospital, Department of Medical Oncology, Osaka, Japan; 11 Japanese foundation for cancer research Cancer Institute Hospital, Department of Thoracic Medical Oncology, Tokyo, Japan; 12 Japanese foundation for cancer research Cancer Institute Hospital, Department of Pharmacy, Tokyo, Japan Background: Chemotherapy-induced nausea and vomiting (CINV) is one of the most unpleasant adverse effects for patients receiving chemotherapy. Resistance to prophylactic antiemetic treatment is a problem, with 30−40% of patients still showing unsatisfactory controll. Efflux transporter in the blood–brain barrier has been suggested as one of the resistance mechanism. Material and Methods: This study was a pharmacogenomics study of a subset of patients previously enrolled in a randomized controlled trial. The aim of this study was to evaluate the role of genetic polymorphisms in the ABCB1 and ABCG2 in cancer patients who were treated with cisplatinbased chemotherapy. The efficacy endpoint was the proportion of patients with complete response during 120 hours after chemotherapy (CR). A total of 156 patients were evaluated and then divided into granisetron
S231 or palonosetron group. The functional polymorphisms of ABCB1 and ABCG2 were genotyped; these genotypes were then investigated for their association with the efficacy of antiemetics in each group, and further their risk factors associated with CINV were examined using logistic regression. Results: No significant association was found for the ABCB1 and ABCG2 polymorphism in the palonosetron group. In the granisetron group, patients with ABCB1 2677TT and 3435TT genotypes had a higher proportion of CR than other genotypes. With univariate analysis, gender and cisplatin dose were associated with granisetron response in addition to ABCB1 2677 and 3435 polymorphisms. The multivariate logistic regression analysis revealed that the ABCB1 3435 polymorphism (OR: 6.73; 95% CI: 1.33–34.08; p = 0.021) and cisplatin dose (OR: 1.09; 95% CI: 1.01–1.18; p = 0.029) were significant predictors of CINV. Conclusions: ABCB1 transporter polymorphisms influenced the extent of CINV control in granisetron, aprepitant and dexamethasone-treated patients. ABCB1 genotypes might be a predictor of antiemetic response. Clinical trial information: UMIN 000009335. No conflict of interest. 1581 POSTER Biosimilar filgrastim treatment patterns and prevention of febrile neutropenia: A multicentric observational national French study in patients with solid tumors (The ZOHe´ study) J.C. Eymard1 , A. Radji2 , R. Diab3 , S. Bordenave4 , E. Assaf5 , C. Aubron-Olivier6 , I. Gasnereau6 , A. Toledano7 , H. Roche´ 8 . 1 Institut ´ ´ eric ´ Jean Godinot, Oncologie Medicale, Reims, France; 2 Centre Fred ´ Joliot, Oncologie Radiotherapie, Rouen, France; 3 Centre hospitalier Emile 4 ˆ Durkheim, Oncologie, Epinal, France; CHU de Nantes − Hopital G&R ¨ Laennec − Saint-Herblain, Service de Pneumologie − Unite´ d’Oncologie 5 ´ Thoracique, Nantes, France; CHU Henri Mondor, Oncologie Medicale, ´ Creteil, France; 6 Sandoz Biopharmaceuticals, Medical Department, 7 Paris, France; American Hospital of Paris, Hartmann Radiotherapy Center, Neuilly, France; 8 Institut Universitaire du Cancer Toulouse − ´ Oncopole, Oncologie Medicale, Toulouse, France Background: Guidelines recommend granulocyte-colony stimulating factor (GCSF) use to reduce the risk of neutropenic infections in patients (pts) receiving chemotherapy (CT). ZOHe´ is a French prospective noninterventional, longitudinal study describing biosimilar filgrastim (Zarzio® ) use in routine practice, in pts receiving CT for solid tumors (ST) or lymphoid malignancies. This analysis reports ST data. Material and Methods: This analysis relates the Zarzio® treatment (tx) characteristics along with CT in terms of dose, day of initiation, and duration. Data were collected prospectively for pts 18 years old at Zarzio® initiation time and 3 months after inclusion. Results: 1174 were recruited from June 2013 to April 2014 (356 (30.3%) breast cancer (BC), 280 (23.8%) lung cancer (LC) and 175 (14.9%) gastrointestinal cancer (GIC)). CT were planned every 21 days in BC or LC (82.3%; 81.4%) and 14 days in GIC (50.3%) (table). 1141 patients were evaluable 3 months after inclusion. Zarzio® was started on average 4.3±2.2 days (median=4) after CT, given for 5±1.5 days (median=5) and the dosing was 33.2±6.9MIU/day (median=30). In 91.8%, the Zarzio® tx was not modified along subsequent CT cycles. Primary prophylaxis (PP) was initiated in 65.8% of cases (25.4% in adjuvant, 36.8% in metastatic disease). 10.7% of pts with a CT regimen associated with a Febrile Neutropenia (FN) risk 20% justified by itself GCSF prophylaxis. However, in pts receiving CT regimen with FN risk of <10%, 10−20%, the vast majority (99.1%) had at least one risk factor for increased incidence of FN such as elderly pts or advanced disease stage. 87 pts (7.6%) developed at least one Grade 3 or 4 neutropenia episode. FN was reported in 40 pts (3.5%) requiring hospitalization for 37 of them. 39 pts had at least one adverse events (AE) considered to be related to GCSF by the investigator (62 non-serious AE, 14 serious AE). 20 AE led to a discontinuation of Zarzio® . Table: CT patterns at inclusion (1174 patients 1174) Type of CT, n, (%) Neo-adjuvant/adjuvant Metastatic Other Current cycle of CT at inclusion, n, (%) C1 C2 C3 Intervals between CT initiation, n, (%) 7 days 14 days 21 days 28 days Other
BC (356)
LC (280)
GIC (175)
Other ST (363)
260 (73) 95 (26.7) 1 (0.3)
47 (16.8) 198 (70.7) 35 (12.5)
34 (19.4) 139 (79.4) 2 (1.2)
99 (27.3) 244 (67.2) 20 (5.5)
241 (67.7) 59 (16.6) 56 (15.7)
203 (72.5) 31 (11.1) 46 (16.4)
74 (42.3) 27 (15.4) 74 (42.3)
255 (70.2) 48 (13.2) 60 (16.5)
36 (10.1) 4 (1.1) 293 (82.3) 7 (2.0) 16 (4.5)
22 (7.8) 1 (0.4) 228 (81.4) 26 (9.3) 3 (1.1)
17 88 19 11 40
37 (10.2) 22 (6.1) 255 (70.2) 32 (8.8) 17 (4.7)
(9.7) (50.3) (10.9) (6.3) (22.8)
S232 Conclusion: This routine practice national French cohort shows that Zarzio® is initiated at day 4 after CT and mostly in PP. 10.7% due to CT regimen associated with a FN risk 20% in accordance with European guidelines, but in the vast majority, because of patient related risk factor. Conflict of interest: Advisory Board: Boheringer, AstraZeneca, Lilly, Sandoz. Other Substantive Relationships: Teva, Hospira, Sandoz. 1582 POSTER Longitudinal study on the impact of patient-reported fatigue on survival in metastatic cancer patients treated with chemotherapy K. Duong1 , E. Fabre2 , F. Scotte2 , J. Medioni2 , B. Rance3 , A. Bouchouicha3 , S. Oudard2 , R. Elaidi1 . 1 Association pour la Recherche ´ ´ ´ de Therapeutiques Innovantes en Cancerologie, Service de Cancerologie ´ ˆ ´ ˆ Medicale Hopital Europeen Georges Pompidou, Paris, France; 2 Hopital ´ ´ ´ Europeen Georges Pompidou, Service de Cancerologie Medicale, 3 ˆ ´ ´ paris, France; Hopital Europeen Georges Pompidou, Departement ` d’Informatique Hospitaliere, Paris, France Background: Fatigue (F) is the most common symptom experienced by cancer patients, especially during chemotherapy (CT). The debilitating effect of fatigue on quality of life was found in many studies but its timevarying effect on survival is still unknown. Whether regularly assessed fatigue during chemotherapy may be prognostic across several solid tumor types was investigated in this study. Methods: We evaluated data of metastatic cancer patients included in the PROCHE program (Oct 2008-Dec 2014, HEGP hospital, Paris). A patient-reported score of fatigue experienced since the last cycle was collected just before each new cycle using the NCI-CTC 5-level scale: none, mild, moderate, severe, and persistently severe. Overall survival (OS) was defined from CT initiation to death or last contact. Baseline F score and average F score (weighted average of F grades during the whole followup period) were analyzed in multivariable Cox models adjusted on age and primary tumor site. Longitudinal analysis of F was performed through k-means clustering analysis (KML) and joint modeling of longitudinal and time-to-event data (JM). Results: Among 2357 patients, 2010 patients were eligible with median age of 64 years (17−94), 49% were male, primary tumor sites were: lung (27%), urogenital (21%), breast (21%), ovary (14%), H&N (12%) and other (4%). OS median was 28 months (95% CI: 25−31), follow-up median was 27 months (26−29), and last follow-up was Apr 2015. Median average F score was 1.14 (IQR, 0.67–1.70). Mild, moderate and severe fatigue (average F score) was experienced by 683 (%, 34), 880 (43) and 463 (23) patients, with medians of OS (m): 45 (95% CI, 38−53), 23 (21−27) and 12 (10−18), respectively. Average F score was associated with OS: HR of 1.66 (95% CI, 1.51–1.83); baseline F score: HR of 1.24 (1.16– 1.33). Fatigue trajectories from KML analyses provided consistent results, among which analysis of fatigue evolution during the first 12 months of CT led to 4 different clusters corresponding to 4 prognostic groups, very good prognosis: no fatigue (median OS, 43m), good prognosis: decreasing fatigue (31m), intermediate: increasing fatigue (22m), poor: established fatigue (17m). Significant association between fatigue and mortality was found upon JM, HR = 2.22 (95% CI, 1.97–2.55) suggesting a more than 2-fold relative increase of death risk for 1 grade increase of F. Conclusion: This large cohort confirmed that patient-reported fatigue was strongly related to survival in metastatic cancer patients. The new finding was that evolution of fatigue was also prognostic: patients with increasing fatigue and persistent severe fatigue had poorer prognosis. Although the effect of fatigue management on survival improvement is still debatable, fatigue should not be overlooked all along patient follow-up. No conflict of interest. 1583 POSTER Conversational support group participation during radiotherapy period helps women with breast cancer and men with prostate cancer A.C. Svensk1 , I. Oster2 , S. Emilsson3 , O. Hedestig2 , B. Tavelin4 , A. Parfa5 , J. Lindh4 . 1 Northern University Hospital, Cancercentrum, ˚ Sweden; 2 Umea˚ University, Radiotherapy Department, Umea, ˚ Sweden; 3 Mellannorrlands hospice AB, Department of Nursing, Umea, Mellannorrlands hospice AB, Sundsvall, Sweden; 4 Umea˚ University, ˚ Sweden; 5 Norrbottens lans ¨ Department of radiation sciences, Umea, ¨ landsting, Forsens halsocentral, Hakkas, Sweden Being diagnosed with breast cancer or prostate cancer can elevate levels of distress and cause depletion of coping resources and strain both physical and mental health. 34 women with breast cancer and 31 men with prostate cancer participated in support groups once a week during the RT period.
Abstracts The controle group: 30 women with breastcancer and 30 men with prostate cancer treated with RT without support group meetings.The aim was to descibe and evaluate the effect of participating in conversational support group during a routine course of radiotherapy. Data collection: Audiotaped group conversations. The paricipants wrote diary notes during the course of radiotherapy. Questionnaires: Coping Resources Inventory/CRI and Hospital Anxiety and Depression Scale/ HADS. Evaluation: before start of RT, at end of RT and 6 months after RT. Diaries: The findings suggest that women with BC found it valuable to be able to share experiences with other women in a similar situation in the context of a support group. Being part of such a group provided a space and an opportunity for reflection. Men: only three men wrote diaries (not evaluated). Questionnaires: Women in the study group showed a significant difference between the study group and control group in the social domain at the second occation of measurement and in the emotional domain at the third occation. Within the study group, over time, increased levels of coping resources reached significant levels concerning the emotional domain at the second occation but were decreased in the same domain within the control group at the third cccation. There were no significant differeces between men in study group and control group concerning coping resources (unpublished data). HADS showed no difference between study and control group for women with BC or for men with PC. Conclusions: Paticipation in a support group during radiotherapy for women with BC is socially and emotionally strengthening because of the opportunity for these patients to mutually share their experiences. This effect has probably impact of their recovery and rehabilitation after treatment. No conflict of interest. 1584 POSTER Serum albumin level and decision of chemotherapy discontinuation in patients with metastatic non-colorectal and colorectal cancer H. Goto1 , N. Handa1 , K. Minakata1 , T. Myojo1 , H. Osawa1 . 1 Edogawa hospital, oncology & hematology, Tokyo, Japan Background: Cancer treatment options have increased with the advent of new drugs. The use of the appropriate drug by the treating physician contributes to patient survival. However, treatment is often continued until the end of the patient’s life. Although the judgment on treatment discontinuation is based on disease progression according to imaging findings, sometimes it is also based on the deterioration of the patient’s general condition, which requires performance status (PS) evaluation. However, the accuracy of PS evaluation by the treating physician may be inadequate, which can result in delayed treatment discontinuation. In this study, we identified indicators for chemotherapy discontinuation other than PS by analyzing patient characteristics and blood data at final treatment. Materials and Methods: We identified patients receiving chemotherapy with non-colorectal (NCRC) and colorectal cancers (CRC) who were died during hospitalization in our institution within a 4-year period, from 2011 to 2014, and retrospectively analyzed their blood data at final treatment (final cycle dqy1), characteristics, and survival. Results: We included 52 NCRC and 54 CRC cases. The median age of the patients with NCRC was 67.5 years (40−85 years), and their median survival was 63 days (5–441 days). Meanwhile, the median age of the patients with CRC was 68 years (49−86 years) and their median survival was 51.5 days (6–1010 days). Multivariate analyses of survival were performed by using the Cox proportional hazards model, with patient characteristics and blood data as variables. The results showed that serum albumin (Alb) level was a significant factor of NCRC (hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.24–0.77 p < 0.01), while C-reactive protein level (HR, 1.07; 95% CI, 1.01–1.13; p = 0.02) and Alb level (HR, 0.50; 95% CI, 0.27–0.94; p = 0.03) were found to be significant factors of CRC. Patients with Alb levels <2.5 g/dL had a median survival of 33 days in NCRC and 21 days in CRC, which were shortened significantly in both groups compared with those with Alb levels >2.5 g/dL (log rank test: NCRC, p < 0.05 and CRC, p < 0.01). In total, only 4 patients (25%) from both groups received nutritional support during final treatment. Conclusions: With decreased Alb levels in both the NCRC and CRC groups, the survival during chemotherapy was also significantly shortened. Anticancer drug treatment initiation in patients with decreased Alb levels has been reported to decrease survival and chemotherapy toxicity. Aggressive nutritional support for patients with decreased Alb levels during treatment is important. In patients with extremely low Alb levels (<2.5 g/dL), the general condition of the patient should be more accurately assessed and the significance of treatment continuation should be reexamined. No conflict of interest.
S231 or palonosetron group. The functional polymorphisms of ABCB1 and ABCG2 were genotyped; these genotypes were then investigated for their association with the efficacy of antiemetics in each group, and further their risk factors associated with CINV were examined using logistic regression. Results: No significant association was found for the ABCB1 and ABCG2 polymorphism in the palonosetron group. In the granisetron group, patients with ABCB1 2677TT and 3435TT genotypes had a higher proportion of CR than other genotypes. With univariate analysis, gender and cisplatin dose were associated with granisetron response in addition to ABCB1 2677 and 3435 polymorphisms. The multivariate logistic regression analysis revealed that the ABCB1 3435 polymorphism (OR: 6.73; 95% CI: 1.33–34.08; p = 0.021) and cisplatin dose (OR: 1.09; 95% CI: 1.01–1.18; p = 0.029) were significant predictors of CINV. Conclusions: ABCB1 transporter polymorphisms influenced the extent of CINV control in granisetron, aprepitant and dexamethasone-treated patients. ABCB1 genotypes might be a predictor of antiemetic response. Clinical trial information: UMIN 000009335. No conflict of interest. 1581 POSTER Biosimilar filgrastim treatment patterns and prevention of febrile neutropenia: A multicentric observational national French study in patients with solid tumors (The ZOHe´ study) J.C. Eymard1 , A. Radji2 , R. Diab3 , S. Bordenave4 , E. Assaf5 , C. Aubron-Olivier6 , I. Gasnereau6 , A. Toledano7 , H. Roche´ 8 . 1 Institut ´ ´ eric ´ Jean Godinot, Oncologie Medicale, Reims, France; 2 Centre Fred ´ Joliot, Oncologie Radiotherapie, Rouen, France; 3 Centre hospitalier Emile 4 ˆ Durkheim, Oncologie, Epinal, France; CHU de Nantes − Hopital G&R ¨ Laennec − Saint-Herblain, Service de Pneumologie − Unite´ d’Oncologie 5 ´ Thoracique, Nantes, France; CHU Henri Mondor, Oncologie Medicale, ´ Creteil, France; 6 Sandoz Biopharmaceuticals, Medical Department, 7 Paris, France; American Hospital of Paris, Hartmann Radiotherapy Center, Neuilly, France; 8 Institut Universitaire du Cancer Toulouse − ´ Oncopole, Oncologie Medicale, Toulouse, France Background: Guidelines recommend granulocyte-colony stimulating factor (GCSF) use to reduce the risk of neutropenic infections in patients (pts) receiving chemotherapy (CT). ZOHe´ is a French prospective noninterventional, longitudinal study describing biosimilar filgrastim (Zarzio® ) use in routine practice, in pts receiving CT for solid tumors (ST) or lymphoid malignancies. This analysis reports ST data. Material and Methods: This analysis relates the Zarzio® treatment (tx) characteristics along with CT in terms of dose, day of initiation, and duration. Data were collected prospectively for pts 18 years old at Zarzio® initiation time and 3 months after inclusion. Results: 1174 were recruited from June 2013 to April 2014 (356 (30.3%) breast cancer (BC), 280 (23.8%) lung cancer (LC) and 175 (14.9%) gastrointestinal cancer (GIC)). CT were planned every 21 days in BC or LC (82.3%; 81.4%) and 14 days in GIC (50.3%) (table). 1141 patients were evaluable 3 months after inclusion. Zarzio® was started on average 4.3±2.2 days (median=4) after CT, given for 5±1.5 days (median=5) and the dosing was 33.2±6.9MIU/day (median=30). In 91.8%, the Zarzio® tx was not modified along subsequent CT cycles. Primary prophylaxis (PP) was initiated in 65.8% of cases (25.4% in adjuvant, 36.8% in metastatic disease). 10.7% of pts with a CT regimen associated with a Febrile Neutropenia (FN) risk 20% justified by itself GCSF prophylaxis. However, in pts receiving CT regimen with FN risk of <10%, 10−20%, the vast majority (99.1%) had at least one risk factor for increased incidence of FN such as elderly pts or advanced disease stage. 87 pts (7.6%) developed at least one Grade 3 or 4 neutropenia episode. FN was reported in 40 pts (3.5%) requiring hospitalization for 37 of them. 39 pts had at least one adverse events (AE) considered to be related to GCSF by the investigator (62 non-serious AE, 14 serious AE). 20 AE led to a discontinuation of Zarzio® . Table: CT patterns at inclusion (1174 patients 1174) Type of CT, n, (%) Neo-adjuvant/adjuvant Metastatic Other Current cycle of CT at inclusion, n, (%) C1 C2 C3 Intervals between CT initiation, n, (%) 7 days 14 days 21 days 28 days Other
BC (356)
LC (280)
GIC (175)
Other ST (363)
260 (73) 95 (26.7) 1 (0.3)
47 (16.8) 198 (70.7) 35 (12.5)
34 (19.4) 139 (79.4) 2 (1.2)
99 (27.3) 244 (67.2) 20 (5.5)
241 (67.7) 59 (16.6) 56 (15.7)
203 (72.5) 31 (11.1) 46 (16.4)
74 (42.3) 27 (15.4) 74 (42.3)
255 (70.2) 48 (13.2) 60 (16.5)
36 (10.1) 4 (1.1) 293 (82.3) 7 (2.0) 16 (4.5)
22 (7.8) 1 (0.4) 228 (81.4) 26 (9.3) 3 (1.1)
17 88 19 11 40
37 (10.2) 22 (6.1) 255 (70.2) 32 (8.8) 17 (4.7)
(9.7) (50.3) (10.9) (6.3) (22.8)
S232 Conclusion: This routine practice national French cohort shows that Zarzio® is initiated at day 4 after CT and mostly in PP. 10.7% due to CT regimen associated with a FN risk 20% in accordance with European guidelines, but in the vast majority, because of patient related risk factor. Conflict of interest: Advisory Board: Boheringer, AstraZeneca, Lilly, Sandoz. Other Substantive Relationships: Teva, Hospira, Sandoz. 1582 POSTER Longitudinal study on the impact of patient-reported fatigue on survival in metastatic cancer patients treated with chemotherapy K. Duong1 , E. Fabre2 , F. Scotte2 , J. Medioni2 , B. Rance3 , A. Bouchouicha3 , S. Oudard2 , R. Elaidi1 . 1 Association pour la Recherche ´ ´ ´ de Therapeutiques Innovantes en Cancerologie, Service de Cancerologie ´ ˆ ´ ˆ Medicale Hopital Europeen Georges Pompidou, Paris, France; 2 Hopital ´ ´ ´ Europeen Georges Pompidou, Service de Cancerologie Medicale, 3 ˆ ´ ´ paris, France; Hopital Europeen Georges Pompidou, Departement ` d’Informatique Hospitaliere, Paris, France Background: Fatigue (F) is the most common symptom experienced by cancer patients, especially during chemotherapy (CT). The debilitating effect of fatigue on quality of life was found in many studies but its timevarying effect on survival is still unknown. Whether regularly assessed fatigue during chemotherapy may be prognostic across several solid tumor types was investigated in this study. Methods: We evaluated data of metastatic cancer patients included in the PROCHE program (Oct 2008-Dec 2014, HEGP hospital, Paris). A patient-reported score of fatigue experienced since the last cycle was collected just before each new cycle using the NCI-CTC 5-level scale: none, mild, moderate, severe, and persistently severe. Overall survival (OS) was defined from CT initiation to death or last contact. Baseline F score and average F score (weighted average of F grades during the whole followup period) were analyzed in multivariable Cox models adjusted on age and primary tumor site. Longitudinal analysis of F was performed through k-means clustering analysis (KML) and joint modeling of longitudinal and time-to-event data (JM). Results: Among 2357 patients, 2010 patients were eligible with median age of 64 years (17−94), 49% were male, primary tumor sites were: lung (27%), urogenital (21%), breast (21%), ovary (14%), H&N (12%) and other (4%). OS median was 28 months (95% CI: 25−31), follow-up median was 27 months (26−29), and last follow-up was Apr 2015. Median average F score was 1.14 (IQR, 0.67–1.70). Mild, moderate and severe fatigue (average F score) was experienced by 683 (%, 34), 880 (43) and 463 (23) patients, with medians of OS (m): 45 (95% CI, 38−53), 23 (21−27) and 12 (10−18), respectively. Average F score was associated with OS: HR of 1.66 (95% CI, 1.51–1.83); baseline F score: HR of 1.24 (1.16– 1.33). Fatigue trajectories from KML analyses provided consistent results, among which analysis of fatigue evolution during the first 12 months of CT led to 4 different clusters corresponding to 4 prognostic groups, very good prognosis: no fatigue (median OS, 43m), good prognosis: decreasing fatigue (31m), intermediate: increasing fatigue (22m), poor: established fatigue (17m). Significant association between fatigue and mortality was found upon JM, HR = 2.22 (95% CI, 1.97–2.55) suggesting a more than 2-fold relative increase of death risk for 1 grade increase of F. Conclusion: This large cohort confirmed that patient-reported fatigue was strongly related to survival in metastatic cancer patients. The new finding was that evolution of fatigue was also prognostic: patients with increasing fatigue and persistent severe fatigue had poorer prognosis. Although the effect of fatigue management on survival improvement is still debatable, fatigue should not be overlooked all along patient follow-up. No conflict of interest. 1583 POSTER Conversational support group participation during radiotherapy period helps women with breast cancer and men with prostate cancer A.C. Svensk1 , I. Oster2 , S. Emilsson3 , O. Hedestig2 , B. Tavelin4 , A. Parfa5 , J. Lindh4 . 1 Northern University Hospital, Cancercentrum, ˚ Sweden; 2 Umea˚ University, Radiotherapy Department, Umea, ˚ Sweden; 3 Mellannorrlands hospice AB, Department of Nursing, Umea, Mellannorrlands hospice AB, Sundsvall, Sweden; 4 Umea˚ University, ˚ Sweden; 5 Norrbottens lans ¨ Department of radiation sciences, Umea, ¨ landsting, Forsens halsocentral, Hakkas, Sweden Being diagnosed with breast cancer or prostate cancer can elevate levels of distress and cause depletion of coping resources and strain both physical and mental health. 34 women with breast cancer and 31 men with prostate cancer participated in support groups once a week during the RT period.
Abstracts The controle group: 30 women with breastcancer and 30 men with prostate cancer treated with RT without support group meetings.The aim was to descibe and evaluate the effect of participating in conversational support group during a routine course of radiotherapy. Data collection: Audiotaped group conversations. The paricipants wrote diary notes during the course of radiotherapy. Questionnaires: Coping Resources Inventory/CRI and Hospital Anxiety and Depression Scale/ HADS. Evaluation: before start of RT, at end of RT and 6 months after RT. Diaries: The findings suggest that women with BC found it valuable to be able to share experiences with other women in a similar situation in the context of a support group. Being part of such a group provided a space and an opportunity for reflection. Men: only three men wrote diaries (not evaluated). Questionnaires: Women in the study group showed a significant difference between the study group and control group in the social domain at the second occation of measurement and in the emotional domain at the third occation. Within the study group, over time, increased levels of coping resources reached significant levels concerning the emotional domain at the second occation but were decreased in the same domain within the control group at the third cccation. There were no significant differeces between men in study group and control group concerning coping resources (unpublished data). HADS showed no difference between study and control group for women with BC or for men with PC. Conclusions: Paticipation in a support group during radiotherapy for women with BC is socially and emotionally strengthening because of the opportunity for these patients to mutually share their experiences. This effect has probably impact of their recovery and rehabilitation after treatment. No conflict of interest. 1584 POSTER Serum albumin level and decision of chemotherapy discontinuation in patients with metastatic non-colorectal and colorectal cancer H. Goto1 , N. Handa1 , K. Minakata1 , T. Myojo1 , H. Osawa1 . 1 Edogawa hospital, oncology & hematology, Tokyo, Japan Background: Cancer treatment options have increased with the advent of new drugs. The use of the appropriate drug by the treating physician contributes to patient survival. However, treatment is often continued until the end of the patient’s life. Although the judgment on treatment discontinuation is based on disease progression according to imaging findings, sometimes it is also based on the deterioration of the patient’s general condition, which requires performance status (PS) evaluation. However, the accuracy of PS evaluation by the treating physician may be inadequate, which can result in delayed treatment discontinuation. In this study, we identified indicators for chemotherapy discontinuation other than PS by analyzing patient characteristics and blood data at final treatment. Materials and Methods: We identified patients receiving chemotherapy with non-colorectal (NCRC) and colorectal cancers (CRC) who were died during hospitalization in our institution within a 4-year period, from 2011 to 2014, and retrospectively analyzed their blood data at final treatment (final cycle dqy1), characteristics, and survival. Results: We included 52 NCRC and 54 CRC cases. The median age of the patients with NCRC was 67.5 years (40−85 years), and their median survival was 63 days (5–441 days). Meanwhile, the median age of the patients with CRC was 68 years (49−86 years) and their median survival was 51.5 days (6–1010 days). Multivariate analyses of survival were performed by using the Cox proportional hazards model, with patient characteristics and blood data as variables. The results showed that serum albumin (Alb) level was a significant factor of NCRC (hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.24–0.77 p < 0.01), while C-reactive protein level (HR, 1.07; 95% CI, 1.01–1.13; p = 0.02) and Alb level (HR, 0.50; 95% CI, 0.27–0.94; p = 0.03) were found to be significant factors of CRC. Patients with Alb levels <2.5 g/dL had a median survival of 33 days in NCRC and 21 days in CRC, which were shortened significantly in both groups compared with those with Alb levels >2.5 g/dL (log rank test: NCRC, p < 0.05 and CRC, p < 0.01). In total, only 4 patients (25%) from both groups received nutritional support during final treatment. Conclusions: With decreased Alb levels in both the NCRC and CRC groups, the survival during chemotherapy was also significantly shortened. Anticancer drug treatment initiation in patients with decreased Alb levels has been reported to decrease survival and chemotherapy toxicity. Aggressive nutritional support for patients with decreased Alb levels during treatment is important. In patients with extremely low Alb levels (<2.5 g/dL), the general condition of the patient should be more accurately assessed and the significance of treatment continuation should be reexamined. No conflict of interest.