Retrospective analysis of chemotherapy for the patients with advanced bladder adenocarcinoma.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 399-399
Author(s):  
Sung Yong Oh ◽  
Young Sam Kim ◽  
Ji Hyun Lee ◽  
Moonjin Kim ◽  
Young Jin Choi ◽  
...  
Keyword(s):  
Retrospective Analysis ◽  
Performance Status ◽  
Malignant Neoplasm ◽  
Progression Free Survival ◽  
Clinical Findings ◽  
Response To Treatment ◽  
Primary Adenocarcinoma ◽  
Urachal Carcinoma ◽  
Metastatic Sites ◽  
Urachal Adenocarcinoma

399 Background: By definition, primary adenocarcinoma of the bladder (PAB) is a malignant neoplasm derived from urothelium of the bladder showing histologically pure glandular differentiation. Because of its rarity, role of chemotherapy for metastatic adenocarcinoma of bladder is still questionable. Therefore, we performed a retrospective analysis of the clinical features and chemotherapy outcomes of metastatic PAB to evaluate the clinical findings at presentation, overall survival (OS) and progression-free survival (PFS) and prognostic factors. Methods: Eligible patients for this retrospective analysis were initially diagnosed with adenocarcinoma and presented with a clinically no other primary site of origin. The collected data included age, gender, performance status, stage, hemoglobin, albumin, initial date of diagnosis, treatment modality utilized, response to treatment, presence of relapse, last status of patient, and last date of follow-up. Results: We retrospectively reviewed 29 patients who treated with chemotherapy as metastatic PAB at 10 Korean medical institutions from 2004 to 2014.The median age of patients was 58 years (range, 17 to 78 years) and 51.7% of the patients were female. Fifteen patients were urachal adenocarcinoma. Of 27 symptomatic patients, 22 experienced gross hematuria. Ten patients had two or more metastatic sites of the lungs (51.7%), peritoneum (41.4%), and ovary (20.7%), as the most common sites. Twelve patients were treated with 5-FU based chemotherapy, 5 were gemcitabine based, 3 were taxane and adriamycin based, and others. 13 of them achieved CR (10.3%) or PR (34.5%). Median PFS and OS for all patients were 10.6 months (95% confidence interval [CI], 9.5 to 11.6 months) and 24.5 months (95% CI, 1.2 to 47.8 months), respectively. In the prognostic factor analysis, the cases of urachal adenocarcinoma had worse tendency in PFS and OS (p=0.024 and P=0.046, respectively). Conclusions: Metastatic Despite most of chemotherapy, PFS and OS were short especially in urachal carcinoma, however, there were some long-term survivors, therefore, additional research on the predictive markers of several clinical, pathological differences and their treatments will be needed.

The prognostic impact of bone metastasis in urothelial carcinoma treated with first-line platinum-based chemotherapy.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 415-415
Author(s):  
Husam Alqaisi ◽  
Zachary William Neil Veitch ◽  
Carlos Stecca ◽  
Jeenan Kaiser ◽  
Scott A. North ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Performance Status ◽  
Progression Free Survival ◽  
Response To Treatment ◽  
Prognostic Impact ◽  
First Line ◽  
Ecog Performance Status ◽  
Cancer Centre ◽  
Platinum Based Chemotherapy ◽  
Line Setting

415 Background: Metastatic urothelial carcinoma (mUC) is an aggressive disease with a median overall survival (OS) of ≈ 15 months. In the first-line setting, key prognostic factors include ECOG performance status, white blood cell count, and response to treatment per the Galsky nomogram. Bone metastases (BM) in mUC are associated with morbidity and mortality but are grouped with visceral disease; hence, their impact on prognosis is not well established. We aimed to assess the survival impact of BM in mUC patients treated with first-line platinum-based chemotherapy (PBC). Methods: A retrospective collection of patient and tumor characteristics, with clinical response to treatment (complete response [CR], partial response [PR]; stable disease [SD] or progressive disease [PD]) for patients treated at Princess Margaret Cancer Centre, Tom Baker Cancer Centre, and Cross Cancer Institute from 2005-2018 was performed. Progression-free survival (PFS) and OS were estimated using the Kaplan-Meier method. Univariate (UVA) followed by multivariate analysis (MVA) of patient variables [Cox] using PFS and OS was performed. Results: Overall 376 mUC patients were included; 222 (59%) had soft-tissue metastases (STM) only, 70 (19%) had bone-only metastases, and 84 (22%) had both STM and BM. Overall, 35% had PR or CR, 19% had SD, and 39% had PD (7%: unknown response). The median PFS and OS for the whole cohort were 5.6 months (95%CI: 4.8-6.4) and 9.7 months (95% CI: 8.8-10.8) respectively. Select UVA by metastatic site showed inferior PFS for bone-only (p=0.03) and combination STM and BM (p=0.017). Only combination STM and BM were significant on UVA for OS (p=0.002). MVA showed that bone-only metastases (p=0.03) and ECOG 3-4 (p<0.0001) were associated with worse PFS (Table). Predictors of worse OS were the combination of STM and BM (p=0.02), ECOG 3-4 (p=0.001), and WBCs ≥ULN (p=0.02), (Table). Conclusions: BM are a significant predictor of worse outcomes for mUC patients treated with first-line PBC. Consideration as a treatment stratification factor for future studies is suggested. Strategies for the treatment of mUC patients with BM (ie: bone targeted agents) in the first-line setting should be addressed in future trials. [Table: see text]

scholarly journals Population Pharmacokinetics/Pharmacodynamics of Dabrafenib Plus Trametinib in Patients with BRAF-Mutated Metastatic Melanoma

Cancers ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 931 ◽  
Author(s):  
David Balakirouchenane ◽  
Sarah Guégan ◽  
Chantal Csajka ◽  
Anne Jouinot ◽  
Valentine Heidelberger ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Systemic Exposure ◽  
Progression Free Survival ◽  
The Elderly ◽  
Cox Models ◽  
Plasma Ratio ◽  
Metastatic Sites

Patients treated with dabrafenib/trametinib (DAB/TRA) exhibit a large interindividual variability in clinical outcomes. The aims of this study were to characterize the pharmacokinetics of DAB, hydroxy-dabrafenib (OHD), and TRA in BRAF-mutated patients and to investigate the exposure–response relationship for toxicity and efficacy in metastatic melanoma (MM) patients. Univariate Fisher and Wilcoxon models including drug systemic exposure (area under the plasma concentration curve, AUC) were used to identify prognostic factors for the onset of dose-limiting toxicities (DLT), and Cox models for overall (OS) and progression-free survival (PFS). Seventy-three BRAF-mutated patients were included in pharmacokinetic (n = 424, NONMEM) and 52 in pharmacokinetic/pharmacodynamic analyses. Age and sex were identified as determinants of DAB and OHD clearances (p < 0.01). MM patients experiencing DLT were overexposed to DAB compared to patients without DLT (AUC: 9624 vs. 7485 ng∙h/mL, respectively, p < 0.01). Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≥ 2 and plasma ratio AUCOHD/AUCDAB ≥ 1 were independently associated with shorter OS (HR: 6.58 (1.29–33.56); p = 0.023 and 10.61 (2.34–48.15), p = 0.022, respectively). A number of metastatic sites ≥3 and cerebral metastases were associated with shorter PFS (HR = 3.25 (1.11–9.50); p = 0.032 and HR = 1.23 (1.35–10.39), p = 0.011; respectively). TRA plasma exposure was neither associated with toxicity nor efficacy. Our results suggest that early drug monitoring could be helpful to prevent the onset of DLT in MM patients, especially in fragile patients such as the elderly. Regarding efficacy, the clinical benefit to monitor plasma ratio AUCOHD/AUCDAB deserves more investigation in a larger cohort of MM patients.

Retrospective analysis of sorafenib as first or second target therapy in mRCC patients in Italian centers: An update.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15524-e15524
Author(s):  
Lisa Derosa ◽  
Angela Gernone ◽  
Franco Morelli ◽  
Teodoro Sava ◽  
Fable Zustovich ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Retrospective Analysis ◽  
Target Therapy ◽  
Performance Status ◽  
Single Agent ◽  
Progression Free Survival ◽  
Complete Response ◽  
Daily Clinical Practice ◽  
Duration Of Treatment ◽  
Ecog Performance Status

e15524 Background: With several agents available for the treatment of metastatic renal cell carcinoma (mRCC) a better understanding of their use in daily clinical practice is fundamental in the decision-making process. Methods: The REtrospective analysis of Sorafenib (So) as 1st or 2nd targET therapy (RESET) in mRCC was a retrospective, observational field study that assessed the use and safety of So in clinical practice in Italian centers. Treatments were determined by physicians per local prescribing guidelines. Patients (pts) treated with So single agent as 1st or 2nd target therapy (TT) for mRCC between 1st Jan 2008 and 31st Dec 2010 were eligible for inclusion. Endpoints included safety, overall survival (OS), progression-free survival, response rate and treatment duration. Subgroup analyses included age, ECOG performance status, prior therapy, number of metastases and line of TT with So. Results: From Feb to Jul 2012, 358 pts from 37 Italian centers were enrolled. The most common ≥ grade 3 drug-related adverse events were hand-foot skin reaction (6.7%), rash (2.2%), hypertension, fatigue and diarrhea (1.7% each). In the overall population, median OS was 17.2 months (mos) (95% CI 15.4 – 19.6 mos) and median PFS was 5.9 mos (95% CI 4.9-6.7 mos). Median duration of treatment with So was 5.03 mos. Disease control (complete response + partial response + stable disease) was observed in 198(56%) pts. In pts receiving So as first or as second TT median OS was 19.9 mos (95% CI 15.9-25.3 mos) and 16.3 mos (95% CI 13.0-18.2 mos) respectively. In the subgroup of pts treated with So 1st TT followed by sunitinib (Su) 2nd TT (44 pts) and Su 1st TT followed by So 2nd TT (173 pts), median OS was 30.4 mos (95% CI 22.0-34.8 mos) and 16.6 mos (95% CI 13.1-18.2 mos) respectively. There were 269(76%) pts that received a total of 2 lines of therapy for mRCC, 133(38%) pts 3 lines and 43(12%) pts 4 lines of therapy. Conclusions: The efficacy and safety profile of So in the setting of Italian community-based daily clinical practice was similar to data reported in prospective clinical trials. The efficacy of So was observed in both the subgroups of pts receiving So as either the first or second TT for mRCC, with intriguing OS data in first line.

Systemic effect of radiotherapy (RT) followed by programmed death 1 (PD-1) inhibitors in non-small-cell lung cancer (NSCLC).

2018 ◽  
Vol 36 (5_suppl) ◽  
pp. 177-177
Author(s):  
Maria Bassanelli ◽  
Diana Giannarelli ◽  
Alain Gelibter ◽  
Fabiana Letizia Cecere ◽  
Rita Chiari ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Performance Status ◽  
Evaluation Criteria ◽  
Progression Free Survival ◽  
Systemic Effect ◽  
Cranial Irradiation ◽  
Response To Treatment ◽  
Abscopal Effect ◽  
Kaplan Meier ◽  
Programmed Death 1

177 Background: RT-induced abscopal effect seems increase the efficacy of immunotherapy. The aim of this study was to evaluate the outcome of patients (pts) with NSCLC previously undergone to RT before receiving PD-1 inhibitors. Methods: We conducted an observational, retrospective analysis of 63 consecutive pts with advanced NSCLC who received RT followed by PD-1 inhibitors at five Italian institutions. Tumor response to treatment was defined according to Response Evaluation Criteria in Solid Tumors version 1.1. Median overall survival (OS) and the 95% confidence interval (CI) were estimated with the Kaplan -Meier method. Results: 63 pts (median age 66 years; male:60.3%) with advanced NSCLC (adenocarcinoma [adc]:71.4%; squamous cells [sqc]:28.6%) were treated with PD-1 inhibitors after RT. RT was delivered a median of 70 days before the start of immunotherapy.47 pts(74.5%)received extracranical RT and 16 pts (25.7%) performed cranial irradiation. Median OS was 11.7 months (mo) [95% CI, 4.7-18.7] (adc: 13.0 mo [95% CI,7.3-18.7], sqc 5.1 mo [95%CI,2.9-7.3]). Median progression free survival (PFS) was 5.1 mo [95% CI,2.5-7.7] (adc: 9.0 mo[ 95% CI,2.6-15.3]; sqc: 3.5 mo [95% CI,2.0-5.1]). A better performance status (PS) according to ECOG scale was associated with an improved OS (PS 0[21 pts]: 15.4 mo [95% CI,10.8-19.9]; PS1[33 pts]: 11.7 mo [95%CI,4.0-19.4]; PS2[9 pts]: 4.1 mo [95% CI,0.9-7.3]). Median OS in 46 pts who received ≤ 1 previous systemic therapy was 13.0 mo [95% CI, 9.4-16.6] and in 17 pts who received ≥2 previous treatments was 7.4 mo [95% CI, 3.1-11.7]. Median OS in 45 pts aged < 70 years was 11.7 mo [95% CI, 4.7-18.7] and in 18 elderly (≥ 70 years) was 6.5 mo [95% CI, 0.0-17.7]. 9(14.3%) partial response, 23(36.5%) stable disease and 25(39.7%) progressive disease have been observed. Conclusions: The synergic combination of RT and PD-1 inhibitors leads to an enhancement of systemic antitumor immune responses, triggering the abscopal effect, resulting in prolonged OS.

Efficacy and safety of second-line nab-paclitaxel plus gemcitabine (nab-P+GEM) after progression on first-line FOLFIRINOX in advanced pancreatic ductal adenocarcinoma (PDAC): Multicenter retrospective analysis.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 689-689
Author(s):  
Changhoon Yoo ◽  
Hyehyun Jeong ◽  
Heejung Chae ◽  
Jaekyung Cheon ◽  
Hong Jae Chon ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Retrospective Analysis ◽  
Performance Status ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Daily Practice ◽  
Common Adverse Event ◽  
Ductal Adenocarcinoma ◽  
Ecog Performance Status ◽  
Line Therapy

689 Background: FOLFIRINOX is one of standard 1st-line regimens for patients (pts) with advanced PDAC. However, there is no globally established 2nd-line regimen after failure of FOLFIRINOX. Although gemcitabine-based regimens are recommended by multiple guidelines and widely used in daily practice, further analysis is needed to reveal the magnitude of clinical benefit with these regimens. Nab-P+Gem is another standard 1st-line regimen for PDAC, but there are limited data as 2nd-line therapy in PDAC. Therefore, we conducted multicenter retrospective analysis of 2nd-line nab-P+Gem after progression on FOLFIRINOX in pts with advanced PDAC. Methods: Between Feb 2016 and Feb 2019, a total of 103 pts with histologically documented PDAC who received nab-P+GEM after progression on 1st-line FOLFIRINOX were identified among 5 referral cancer centers in South Korea. Results: Median age was 60 years and 50 pts (49%) were male. All but one pts had ECOG performance status of 0-1 at the time of nab-P+GEM. At the time of nab-P+GEM, 25 (24%) and 78 (76%) patients had locally advanced and metastatic disease, respectively. Median overall survival (OS) and progression-free survival (PFS) with nab-P+GEM was 9.8 months (95% CI: 8.9-10.6) and 4.6 months (95% CI: 3.7-5.5), respectively. Among pts with measurable disease (n = 95), partial response and stable disease were achieved in 8 (8%) and 56 (54%), respectively. Median OS from the start of 1st-line FOLFIRINOX was 20.9 months (95% CI: 15.2-26.6). Most common adverse event of all grade was anemia (77%), followed by neutropenia (60%), fatigue (52%), thrombocytopenia (45%), and peripheral neuropathy (30%). Most common grade 3-4 adverse events were neutropenia (36%), anemia (9%), and peripheral neuropathy (8%). Conclusions: In medically fit pts with advanced PDAC who failed on 1st-line FOLFIRINOX, nab-P+GEM was effective and well tolerated as 2nd-line therapy.

scholarly journals Folfirinox versus gemcitabine/nab-paclitaxel as first-line therapy in patients with metastatic pancreatic cancer: a comparative propensity score study

2019 ◽  
Vol 12 ◽  
pp. 175628481987866 ◽  
Author(s):  
Nicolas Williet ◽  
Angélique Saint ◽  
Anne-Laure Pointet ◽  
David Tougeron ◽  
Simon Pernot ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Propensity Score ◽  
Liver Metastases ◽  
Performance Status ◽  
Progression Free Survival ◽  
Metastatic Pancreatic Cancer ◽  
First Line ◽  
First Line Therapy ◽  
Reverse Sequence ◽  
Metastatic Sites

Background: Folfirinox (FFX) and gemcitabine/nab-paclitaxel (GN) are both standard first-line treatments in patients with metastatic pancreatic cancer (mPC). However, data comparing these two chemotherapeutic regimens and their sequential use remain scarce. Methods: Data from two independent cohorts enrolling patients treated with FFX ( n = 107) or GN ( n = 109) were retrospectively pooled. Primary endpoint was overall survival (OS). Progression-free survival (PFS) was the secondary endpoint. A propensity score based on age, gender, performance status (PS), and presence of liver metastases was used to make groups comparable. Results: In the whole study population, OS was significantly higher in FFX (14 months; 95% CI: 10–21) than in GN groups (9 months; 95% CI: 8–12) before ( p = 0.008) and after ( p = 0.021) adjusting for age, number of metastatic sites, liver metastases, peritoneal carcinomatosis and CA19.9 level at baseline. PFS tends to be higher in FFX (6 months) than GN groups (5 months; p = 0.053). After matching ( n = 49/group), patients were comparable for all baseline characteristics including PS. In the matched population, there was a trend toward greater OS in patients treated with FFX (HR = 0.67; p = 0.097). However, survival in each group was not solely a result of the first-line regimen. The proportion of patients who were fit for GN after FFX failure (FFX–GN sequence) was higher (46.9%) than the reverse sequence (20.4%; p = 0.01), which suggests a higher feasibility for the FFX–GN sequence. Corresponding median OS were 19 months versus 9.5 months, respectively ( p = 0.094). Conclusion: This study shows greater OS with FFX than with GN in patients with mPC. GN after FFX failure appears more feasible than the reverse sequence.

Advanced chondrosarcomas: Role of chemotherapy and survival.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 10023-10023
Author(s):  
Binh Bui Nguyen ◽  
Angela Cioffi ◽  
Sophie Piperno-Neumann ◽  
Loic Chaigneau ◽  
François Bertucci ◽  
...  
Keyword(s):  
Performance Status ◽  
Objective Response ◽  
Pegylated Liposomal Doxorubicin ◽  
Progression Free Survival ◽  
Best Supportive Care ◽  
Progression Rate ◽  
Free Survival ◽  
Investigational Drugs ◽  
Metastatic Sites

10023 Background: There are no data about the role of chemotherapy in patients with advanced chondrosarcomas. Methods: From 2000 to 2011, 98 patients with a confirmed diagnosis of advanced chondrosarcomas were referred to one of the 8 participating institutions, and their medical records reviewed. Results: Median age was 46 years (range 16-82). The most frequent histological subtype was conventional chondrosarcoma (n=60, 61%). 83 patients (85%) had metastatic disease ( lung n=71, bone n=23, liver n=6) and 15 patients (15%) had locoregional unresectable disease. 30 patients (31%) had ≥ 2 metastatic sites. 63 patients (64%) received 1st-line combination agent chemotherapy. 70 patients (71%) received a 1st-line anthracycline-containing regimen (doxorubicin + cisplatin +/- ifosfamide: n=30, doxorubicin or pegylated liposomal doxorubicin: n=18, doxorubicin + ifosfamide +/- dacarbazine: n=16, others= 6). RECIST objective response was observed in 14 patients (14%), all but two treated with anthracyclines. 30 patients (31%) had stable disease > 6 months. Median progression-free survival (PFS) and overall survival (OS) were 5.3 months (95% CI: 2.8-7.7) and 19 months (95% CI: 14-24) respectively. Performance status (PS) ≥ 2 was the sole factor significantly associated with OS. Conclusions: Chemotherapy is associated with a 6-month non-progression rate of about 45% in patients with advanced chondrosarcoma. Best supportive care should be considered in patients with poor PS. These data should be used as a reference for response and outcome in the assessment of investigational drugs in advanced chondrosarcoma.

Circadian rest-activity rhythm as a predictor of survival in metastatic colorectal cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14006-e14006 ◽  
Author(s):  
David Spiegel ◽  
Pierre-Antoine Dugué ◽  
Pasquale F. Innominato ◽  
Abdoulaye Karaboué ◽  
Garance Dispersyn ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Cancer Progression ◽  
Activity Rhythm ◽  
Performance Status ◽  
Progression Free Survival ◽  
Adjusted Relative Risk ◽  
Circadian Timing System ◽  
Metastatic Sites ◽  
Rest Activity

e14006 Background: Experimental disruption of the Circadian Timing System (CTS) accelerates cancer progression. The relative amount of activity in-bed versus out-of-bed (I<O) was identified as a quantitative CTS estimate that predicted survival in two cohorts of patients with metastatic colorectal cancer (CI, CII). Methods: The independent prognostic value of I<O was investigated for Overall Survival (OS) and Progression-Free Survival (PFS) 1) in a new cohort of 142 patients (CIII) receiving circadian-based salvage treatment for metastatic colorectal cancer, and 2) in a pooled population of 436 patients from cohorts I-III. All patients had two-day rest-activity rhythm monitoring and then received a new treatment. Cohort-adjusted data were analyzed with log rank and multivariate Cox analyses. Results: Patients in CIII had poor prognosis disease compared to CI and CII, as assessed by prior chemotherapy (CIII, 69%; CI, 59.5%; CII, none), prior oxaliplatin (CIII, 55%; CII, none; CI, 2%) and/or irinotecan (CIII, 39.4%; CII, none; CI, 7%). The 273 male and 163 female patients in the pooled population had generally good performance status 0 (60.7%) or 1 (33.1%) and 51% had two or more metastatic sites. Following rest-activity rhythm determination, patients received a median of 8 chemotherapy courses. Median OS was 21.6 months [95% Confidence Limits, 17.8 to 25.5] in the patients with I<O above the cutoff median value of 97.5% as compared to 11.9 months [10.4 to 13.3] in those with a lower I<O (p from Log rank < 0.001). The adjusted relative risk related to I<O above cutoff was 0.587 [0.477 to 0.722] for earlier death (p<0.001) and 0.661 [0.542 to 0.807] for earlier progression (p <0.001). Conclusions: The circadian biomarker indicator I<O is a robust and independent quantitative long-term predictor of both OS and PFS in patients with metastatic colorectal cancer. Cancer patients with low I<O could potentially benefit from specific treatments for circadian disruption in order to enhance survival.

Regional differences in patient (pt) characteristics of AVAGAST: An exploratory comparison in chemotherapy plus placebo (PL) arm between Japanese (JPN) and the rest of the world (ROW) pts.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 100-100
Author(s):  
Tomohira Nishina ◽  
Akira Sawaki ◽  
Kensei Yamaguchi ◽  
Toshihiko Doi ◽  
Yasuhide Yamada ◽  
...  
Keyword(s):  
Tumor Size ◽  
Regional Differences ◽  
Performance Status ◽  
Progression Free Survival ◽  
Disease Status ◽  
Exploratory Analysis ◽  
Proportional Hazard ◽  
The Difference ◽  
Neo Adjuvant Chemotherapy ◽  
Metastatic Sites

100 Background: AVAGAST study showed regional differences in efficacy, including notable differences in progression free survival (PFS) and overall survival in the PL arm. In Japan, there is a certain number of pts with minimal peritoneal metastasis (PM) diagnosed only by laparoscopy or open surgery, which seems unusual in Western as well as in other Asian countries, and it might have led the differences. Therefore, an exploratory analysis was conducted among the PL arm to examine pt characteristics including PM associated with differences in outcome between JPN and ROW. Methods: We compared PFS of PL arm between pts enrolled from JPN and those from ROW. Hazard ratio (HR) and its 95% confidence interval (95%CI) between JPN and ROW were calculated using Cox’s proportional hazard model for each major covariates (disease status, performance status, prior gastrectomy, prior (neo)adjuvant chemotherapy, age, sex, primary site, liver metastasis (mets), number of metastatic sites, disease measurability, histologic type, maximum of tumor size, sum of tumor size, bone mets, PM and only PM) Results: 188 pts from 14 sites were enrolled from JPN, of which 94 pts were randomized to PL arm. Compared with 293 pts from ROW in PL arm, PFS tend to be favorable in JPN. Subgroups of JPN without liver mets, with diffuse or mixed type gastric cancer (GC), with PM and with only PM were clearly favorable than that of ROW. The difference in subgroup with PM was especially large with lower confidence limit of 1.21. When the pts with only PM were excluded, the difference of PFS in PL arm between JPN and ROW became smaller ( Table ). Conclusions: In this exploratory analysis, pts with PM in JPN had a better prognosis than ROW pts. Understanding this unique pt population may provide insight to the regional differences in outcome noted on this study. [Table: see text]

Long-term benefit (LTB) of sunitinib (SU) treatment for metastatic renal cell carcinoma (mRCC): Retrospective analysis for clinical biomarkers identification.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 465-465
Author(s):  
Oren Smaletz ◽  
Matias Chacon ◽  
Ludmila de Oliveira Koch ◽  
Daniela Regina de Carvalho Rocha ◽  
Fernanda Camila Cardoso
Keyword(s):  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Retrospective Chart Review ◽  
Progression Free Survival ◽  
Predictive Marker ◽  
Common Finding ◽  
Second Line ◽  
Clinical Biomarkers ◽  
Metastatic Sites

465 Background: Prospective studies with sunitinib in mRCC have shown median progression-free survival (mPFS) of 11 months (first line) and 8.3 months (second line). In order to identify patients with LTB with SU, we describe the clinical characteristics of patients with mRCC treated with SU with an mPFS of 15 months or more. Methods: This is a retrospective chart review of patients with mRCC treated with SU in two hospitals, Alexander Fleming Institute Buenos Aires in Argentina and Hospital Israelita Albert Einstein in Sao Paulo, Brazil. Inclusion criteria included patients treated with SU who had a PFS of at least 15 months. Results: Between September 1995 and August 2009, 29 cases were identified. Patient demographics were: median age of 56 years, 65% male, 96% with previous nephrectomy, Eastern Cooperative Oncology Group performance status (PS) of either 0 (52%) or 1 (48%), 93% had clear cell histology, 69% received prior systemic therapy, and 78% had ≤ 2 metastatic sites (mostly in the lungs, liver and bone). Patients were started on SU 50 mg 4 weeks on treatment/2 weeks off treatment (4/2) (n=26) or 37.5 mg 6 weeks continuous dosing (n=3). For those patients starting on 4/2, dose reduction was necessary in 59% of the patients to maintain SU therapy. Median duration of therapy was 23.7 months. During treatment, 24 patients (83%) developed hypertension. Response rates were as follows: complete response 7% (n=2), partial response 38% (n=11), stable disease 52% (n=15); data missing for one patient. Conclusions: LTB is seen in patients who are young, have good performance status, and either 1 or 2 metastatic sites. Dose reductions are common in order to maintain treatment while benefiting from SU. Treatment with SU as either first- or second-line therapy did not appear to influence outcome. Hypertension is a common finding and serves as a predictive marker during treatment, but study limitations preclude the identification of pre-treatment predictive factors.

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