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P0084 Eribulin in patients with advanced urothelial cancer and previously treated with platinum and anti-microtubule chemotherapy: A phase 2 California Cancer Consortium trial
Abstracts / 51 (2015) e1–e36
morbidity. The morbidity and mortality rates declined with increases in hospital volume of patients and experience of the surgeon doing the procedure. Interpretation: D2 gastrectomy for stomach carcinomas can be performed safely in specialised centres with low morbidity and mortality rates. http://dx.doi.org/10.1016/j.ejca.2015.06.051
P0080 INCIDENCE AND ASSOCIATED FACTORS OF CISPLATININDUCED CHRONIC KIDNEY DISEASE AFTER CHEMORADIOTHERAPY FOR NASOPHARYNGEAL CARCINOMA K. Mahaprom *, A. Nongnuch, E. Sirachainan, N. Ngamphaiboon. Ramathibodi Hospital, Mahidol University, Salaya, Phutthamonthon District, Nakhon Pathom, Thailand Background: Cisplatin-based chemoradiotherapy (CRT) is effective and considered a standard of care for treatment of locally advanced nasopharyngeal carcinoma (NPC). Cisplatin-induced nephrotoxicity is problematic in this group of patients because they usually have poor oral intake, dehydration, and malnutrition. Acute kidney injury (AKI) during treatment is a well-known complication that leads to cisplatin discontinuation. However, cisplatin-induced chronic kidney disease (CI-CKD) may not be noticeable during CRT. Methods: Patients with non-metastatic NPC who underwent cisplatin-based CRT at Ramathibodi Hospital (Nakhon Pathom, Thailand) between January 2007, and December 2012, were identified through the Ramathibodi Cancer Registry database. Patient characteristics, treatments, baseline, and post-treatment creatinine (66 months after the last dose of chemotherapy) were abstracted. Estimated glomerular filtration rate (eGFR) was calculated by the CKD EPI formula. Patients with AKI were excluded. Primary endpoint was an incidence of CI-CKD, defined by the reduction of eGFR of 20 mg/dl or more from baseline. Findings: 245 patients with NPC were identified. 115 eligible patients were included for analysis. All patients had an Eastern Cooperative Oncology Group status of 0–1. Median follow-up was 34.2 months. Overall, CI-CKD was observed in 36 (31%) of 115 patients. Multivariable analysis revealed being female and having a higher total dose of cisplatin during CRT were significantly associated with an increased risk of CI-CKD. Interpretation: Approximately a third of patients with NPC suffered from CI-CKD after completion of treatment with cisplatin-based CRT. Total dose of cisplatin during CRT was strongly associated with CI-CKD despite patients being of a young age and with a high baseline eGFR. http://dx.doi.org/10.1016/j.ejca.2015.06.052
P0084 ERIBULIN IN PATIENTS WITH ADVANCED UROTHELIAL CANCER AND PREVIOUSLY TREATED WITH PLATINUM AND ANTI-MICROTUBULE CHEMOTHERAPY: A PHASE 2 CALIFORNIA CANCER CONSORTIUM TRIAL D.I. Quinn a,*, P.W. Twardowski b, N. Ruel b, S.G. Groshen a, T.B. Dorff b, S.K. Pal a, W.M. Stadler d, D.R. Gandara c,
e17
P.N. Lara Jr c, E.M. Newman b. a University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA, b City of Hope National Medical Center, Duarte, CA, USA, c University of California, Davis, CA, USA, d University of Chicago, Phoenix, IL, USA Background: There is an unmet need for new agents in advanced urothelial cancer (UC). Antimicrotubule therapy (AMT; e.g. vincas and taxanes) has activity in UC. We previously reported that eribulin, a microtubule modulator derived from the black Pacific sea sponge, is highly active against metastatic UC in the clinical frontline setting and in patients who are treated with platinum but are naive to_AMT. Here, we report the results of a phase 2 study of patients with UC and previously treated with platinum and AMT. Methods: Eligible patients had UC of any histological type, calculated creatinine clearance of 20 mL/m2 or more, and previously treated with platinum and AMT. Eribulin at 1.4 mg/m2 was intravenously given on days 1 and 8, every 3 weeks. Overall response rate (RR) of more than 20% was considered promising for further study; 41 patients were required in a Simon two-stage design. Progression-free survival (PFS) and overall survival (OS) were secondary endpoints. Findings: Of 44 patients entered in this study, 37 were evaluated (seven too early). Patients included had a median age 68 years (range 25–86 years); 61% were men; Karnofsky performance score of 90% of more in 58% of patients; transitional cell histology 36 (86%); and Bajorin risk groups: 0: 23%, 1: 61%, 2: 16% (relative risk 25%, 95% confidence interval (CI) 12–38), including two complete responses and nine partial responses. Stable disease for more than 12 weeks was seen in 12 (27%) patients. At median 5.5 months of follow-up, median PFS was 3.9 months (2.8–5.1). Median OS was 8.4 months (5.3–14.0). PFS was associated with Bajorin risk group (p = 0.02 for trend). Toxicities included grade 3 or 4 neutropenia in 25 (57%) patients, febrile neutropenia (none reported), grade 3 anaemia in seven (16%) patients, and grade 1 or 2 sensory neuropathy in 17 (39%) patients. Interpretation: Eribulin has highly encouraging single agent activity in patients with advanced UC and previously treated with platinum and AMT. Phase 3 evaluation of eribulin in advanced UC is warranted. (NCT00365157; UM1 CA186717; U01 CA062505; P30 CA01408; P30 CA033572).
http://dx.doi.org/10.1016/j.ejca.2015.06.053
P0089 PROGNOSTIC FACTORS FOR NODE-POSITIVE BREAST CANCER AFTER SURGERY, CHEMOTHERAPY, AND RADIOTHERAPY C.C. Liang *, C.P. Pi. Department of Radiation Oncology, Changhua Christian Hospital, Changhua, Taiwan Background: Breast cancer is the most common cancer among women. Surgery plus chemotherapy and radiotherapy is the major treatment used for node-positive breast cancer. The purpose of this study was to analyse the prognostic and predictive factors that relate to outcome in node-positive breast cancer after surgery, chemotherapy, and radiotherapy. Methods: Patients diagnosed with node-positive breast cancer and who received surgery, neoadjuvant, or adjuvant chemotherapy plus adjuvant radiotherapy at our institution (Changhua Christian Hospital, Changhua, Taiwan) from June 2008, to March 2011, were surveyed retrospectively. Factors such as age at diagnosis, histological grade, T stage, N stage, types of surgery, some pathological factors, hormone receptor status, history of diabetes mellitus or hypertension,
morbidity. The morbidity and mortality rates declined with increases in hospital volume of patients and experience of the surgeon doing the procedure. Interpretation: D2 gastrectomy for stomach carcinomas can be performed safely in specialised centres with low morbidity and mortality rates. http://dx.doi.org/10.1016/j.ejca.2015.06.051
P0080 INCIDENCE AND ASSOCIATED FACTORS OF CISPLATININDUCED CHRONIC KIDNEY DISEASE AFTER CHEMORADIOTHERAPY FOR NASOPHARYNGEAL CARCINOMA K. Mahaprom *, A. Nongnuch, E. Sirachainan, N. Ngamphaiboon. Ramathibodi Hospital, Mahidol University, Salaya, Phutthamonthon District, Nakhon Pathom, Thailand Background: Cisplatin-based chemoradiotherapy (CRT) is effective and considered a standard of care for treatment of locally advanced nasopharyngeal carcinoma (NPC). Cisplatin-induced nephrotoxicity is problematic in this group of patients because they usually have poor oral intake, dehydration, and malnutrition. Acute kidney injury (AKI) during treatment is a well-known complication that leads to cisplatin discontinuation. However, cisplatin-induced chronic kidney disease (CI-CKD) may not be noticeable during CRT. Methods: Patients with non-metastatic NPC who underwent cisplatin-based CRT at Ramathibodi Hospital (Nakhon Pathom, Thailand) between January 2007, and December 2012, were identified through the Ramathibodi Cancer Registry database. Patient characteristics, treatments, baseline, and post-treatment creatinine (66 months after the last dose of chemotherapy) were abstracted. Estimated glomerular filtration rate (eGFR) was calculated by the CKD EPI formula. Patients with AKI were excluded. Primary endpoint was an incidence of CI-CKD, defined by the reduction of eGFR of 20 mg/dl or more from baseline. Findings: 245 patients with NPC were identified. 115 eligible patients were included for analysis. All patients had an Eastern Cooperative Oncology Group status of 0–1. Median follow-up was 34.2 months. Overall, CI-CKD was observed in 36 (31%) of 115 patients. Multivariable analysis revealed being female and having a higher total dose of cisplatin during CRT were significantly associated with an increased risk of CI-CKD. Interpretation: Approximately a third of patients with NPC suffered from CI-CKD after completion of treatment with cisplatin-based CRT. Total dose of cisplatin during CRT was strongly associated with CI-CKD despite patients being of a young age and with a high baseline eGFR. http://dx.doi.org/10.1016/j.ejca.2015.06.052
P0084 ERIBULIN IN PATIENTS WITH ADVANCED UROTHELIAL CANCER AND PREVIOUSLY TREATED WITH PLATINUM AND ANTI-MICROTUBULE CHEMOTHERAPY: A PHASE 2 CALIFORNIA CANCER CONSORTIUM TRIAL D.I. Quinn a,*, P.W. Twardowski b, N. Ruel b, S.G. Groshen a, T.B. Dorff b, S.K. Pal a, W.M. Stadler d, D.R. Gandara c,
e17
P.N. Lara Jr c, E.M. Newman b. a University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA, b City of Hope National Medical Center, Duarte, CA, USA, c University of California, Davis, CA, USA, d University of Chicago, Phoenix, IL, USA Background: There is an unmet need for new agents in advanced urothelial cancer (UC). Antimicrotubule therapy (AMT; e.g. vincas and taxanes) has activity in UC. We previously reported that eribulin, a microtubule modulator derived from the black Pacific sea sponge, is highly active against metastatic UC in the clinical frontline setting and in patients who are treated with platinum but are naive to_AMT. Here, we report the results of a phase 2 study of patients with UC and previously treated with platinum and AMT. Methods: Eligible patients had UC of any histological type, calculated creatinine clearance of 20 mL/m2 or more, and previously treated with platinum and AMT. Eribulin at 1.4 mg/m2 was intravenously given on days 1 and 8, every 3 weeks. Overall response rate (RR) of more than 20% was considered promising for further study; 41 patients were required in a Simon two-stage design. Progression-free survival (PFS) and overall survival (OS) were secondary endpoints. Findings: Of 44 patients entered in this study, 37 were evaluated (seven too early). Patients included had a median age 68 years (range 25–86 years); 61% were men; Karnofsky performance score of 90% of more in 58% of patients; transitional cell histology 36 (86%); and Bajorin risk groups: 0: 23%, 1: 61%, 2: 16% (relative risk 25%, 95% confidence interval (CI) 12–38), including two complete responses and nine partial responses. Stable disease for more than 12 weeks was seen in 12 (27%) patients. At median 5.5 months of follow-up, median PFS was 3.9 months (2.8–5.1). Median OS was 8.4 months (5.3–14.0). PFS was associated with Bajorin risk group (p = 0.02 for trend). Toxicities included grade 3 or 4 neutropenia in 25 (57%) patients, febrile neutropenia (none reported), grade 3 anaemia in seven (16%) patients, and grade 1 or 2 sensory neuropathy in 17 (39%) patients. Interpretation: Eribulin has highly encouraging single agent activity in patients with advanced UC and previously treated with platinum and AMT. Phase 3 evaluation of eribulin in advanced UC is warranted. (NCT00365157; UM1 CA186717; U01 CA062505; P30 CA01408; P30 CA033572).
http://dx.doi.org/10.1016/j.ejca.2015.06.053
P0089 PROGNOSTIC FACTORS FOR NODE-POSITIVE BREAST CANCER AFTER SURGERY, CHEMOTHERAPY, AND RADIOTHERAPY C.C. Liang *, C.P. Pi. Department of Radiation Oncology, Changhua Christian Hospital, Changhua, Taiwan Background: Breast cancer is the most common cancer among women. Surgery plus chemotherapy and radiotherapy is the major treatment used for node-positive breast cancer. The purpose of this study was to analyse the prognostic and predictive factors that relate to outcome in node-positive breast cancer after surgery, chemotherapy, and radiotherapy. Methods: Patients diagnosed with node-positive breast cancer and who received surgery, neoadjuvant, or adjuvant chemotherapy plus adjuvant radiotherapy at our institution (Changhua Christian Hospital, Changhua, Taiwan) from June 2008, to March 2011, were surveyed retrospectively. Factors such as age at diagnosis, histological grade, T stage, N stage, types of surgery, some pathological factors, hormone receptor status, history of diabetes mellitus or hypertension,