Cholangiocarcinoma: A joint cancer database analysis.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 268-268
Author(s):  
Yehuda Ethan Deutsch ◽  
Danny Sleeman ◽  
Afonso Ribeiro ◽  
Dido Franceschi ◽  
Peter Joel Hosein ◽  
...  
Keyword(s):  
Bile Duct ◽  
Surgical Resection ◽  
Survival Benefit ◽  
Positive Impact ◽  
Performance Status ◽  
Palliative Therapy ◽  
Stage Iv ◽  
Ampulla Of Vater ◽  
Stage Iii ◽  
Biliary Cancer

268 Background: Cholangiocarcinoma is an uncommon malignancy. In addition, only 10-30% of patients are eligible for curative surgical resection due to advanced disease at diagnosis. The role of adjuvant therapy is not yet established. The objective of this analysis is to assess the outcome of patients with cholangiocarcinoma managed with surgery, chemotherapy, radiation, and/or chemo-radiation. Methods: From 1997 to 2007, patients with biliary cancer from the joint tumor registry database at UMH, SCCC, and JHS had their demographics, stage, pathology, treatment (surgical management, adjuvant and palliative therapy) and survival collected. A total of 800 patients with the diagnoses of biliary cancer were reviewed. The site of cancer was the bile duct in 351 patients, gallbladder in 173, and ampulla of vater in 239 patients. Results: Cholangiocarcinoma - adenocarcinoma of the bile duct – in 334 patients of the 351 with bile duct tumors were analyzed. The mean age at diagnosis was 65 (range 26-92) and 55% of patients were male. Stage at presentation was as follows: 22% of patients presented with stage I, 18% with stage II, 21% with stage III, 26% with stage IV, and 13% were unknown. Potentially curative surgical resection was performed in 45% of the patients. 24% received chemotherapy, 20% received radiation, and 14% received chemo-radiation in combination. The overall median survival (MS) of all patients was 13 months - 22, 16, 14, and 10 months for stages I, II, III, and IV respectively. Surgery provided an overall survival benefit for all stages (24 vs. 9 months, p<.001), including stage III (n=31/71; 20 vs. 10 months, p=.026) and stage IV (n=28/88; 23 vs. 6 months, p<.001). Chemotherapy offered a trend to survival benefit for patients with stage IV (13 vs. 6 months, p=.06) and combined stages III and IV (13 vs. 10 months, p=.07). Combination chemo-radiation had a significant survival benefit in stage IV (19 vs. 6 months, p=.022) and in combined stages III and IV (14 vs. 10 months, p=.026). Conclusions: Chemotherapy and chemo-radiation had a positive impact on survival in patients with late stage cholangiocarcinoma. Surgery improved survival in both early and advanced stages. The lack of data on performance status and organ function did not allow factoring these variables in the analysis.

Surgical Management of Advanced Adrenocortical Carcinoma: A 21-year Population-based Analysis

2013 ◽  
Vol 79 (10) ◽  
pp. 1115-1118 ◽  
Author(s):  
Thuy B. Tran ◽  
Douglas Liou ◽  
Vijay G. Menon ◽  
Nicholas N. Nissen
Keyword(s):  
Surgical Resection ◽  
Adrenocortical Carcinoma ◽  
Univariate Analysis ◽  
Survival Rates ◽  
Stage Iv ◽  
Population Based ◽  
Stage Iii ◽  
Dismal Prognosis ◽  
Advanced Stages ◽  
The Impact

Adrenocortical carcinoma (ACC) is a rare endocrine malignancy with a dismal prognosis. When diagnosed in advanced stages of the disease, the outcomes of surgical resection are not well understood. The objective of this study is to determine the impact of surgery in patients with advanced ACC. Using the Surveillance, Epidemiology and End Results database, we identified patients diagnosed with Stage III and IVACC between 1988 and 2009. A total of 320 patients with Stage III and IV disease were included in our analysis. In patients treated with surgical resection, the Stage III 1- and 5-year survival rates were 77 and 40 per cent, respectively, whereas the Stage IV 1- and 5-year survival rates were 54 and 27.6 per cent, respectively. Patients treated without surgery had poor survival at 1 year for both Stage III (13%) and Stage IV (16%) ( P < 0.01 compared with the surgical groups). Lymph node dissection was performed in 26 per cent of the patients with advanced ACC and was associated with improved survival in univariate analysis of Stage IV patients. Overall, our results indicate that favorable survival outcomes can be achieved even in patients with Stage III and IV disease and surgery should be considered in patients with advanced ACC.

Potential of surgery and chemotherapy in patients with second metastatic recurrence after R0-resection of colorectal liver metastases.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 644-644
Author(s):  
Kia Homayounfar ◽  
Annalen Bleckmann ◽  
Lena Conradi ◽  
Thilo Sprenger ◽  
Martin Niessner ◽  
...  
Keyword(s):  
Liver Metastases ◽  
Surgical Resection ◽  
Survival Benefit ◽  
Palliative Therapy ◽  
Standard Of Care ◽  
Best Supportive Care ◽  
Single Site ◽  
Colorectal Metastases ◽  
R0 Resection ◽  
Metastatic Recurrence

644 Background: Surgical resection is the standard of care for resectable colorectal metastases (CRM). Preoperative chemotherapy allows assessment of tumorbiology and has been shown to convert approximately 30% of unresectable patients into secondary resectability. In patients with second metastatic recurrence (SMR), complete (R0) resection of all metastases seems to be accompanied with a survival benefit. The role of chemotherapy is unclear. Methods: Between 01/2001 and 31/08/2011 R0-resection could be achieved in 178 patients with liver only CRM at our institution. 103 patients developed SMR 10.4 ± 8.9 months after R0-resection of hepatic CRM. Of these, 79 patients had perioperative 5FU-based chemotherapy for treatment of the primary tumor and/or first liver metastases. Median follow-up from diagnosis of SMR was 21 (range 1-80) months. Results: SMR occurred in 80 patients at a single site (48x liver, 18x lung, 14x other) and in 23 patients at multiple sites (11x liver and lung, 7x including lung, 4x including liver, 1x other). 9 patients refused therapy and received best supportive care. 42 patients with single site recurrence were scheduled for primary surgery. R0-resection could be achieved in 26 patients (62%). 52 patients were treated with 8.1 ± 8 cycles of 5FU-based chemotherapy (5x 5FU/FS, 21x FOLFOX, 26x FOLFIRI) extended by the EGFR-antibody cetuximab (n=9) or the VEGF-antibody bevacizumab (n=18). 9 of these patients were scheduled for surgical exploration. R0-resection could be achieved in 5 patients with single site and 2 patients with multiple site recurrence. Morbidity and mortality rates for all operated patients were 16% and 0%, respectively. 5-years DFS rate for R0-resected patients was 20%. 5-years OS rate were 43% for R0-resected patients versus 11% for patients with R1/2 resection and palliative therapy (p<0.001). Conclusions: Surgical resection of SMR offers a survival benefit and became possible even in 7 of 52 patients (13%) initially treated by chemotherapy. Therefore, all therapeutic options should be used in patients with SMR to achieve R0-resection of CRM.

Colorectal carcinoma (CRC) management approach in octogenarians and over a single institute experience.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 575-575
Author(s):  
Emmet Jordan ◽  
Amy Murphy ◽  
Seamus Coyle ◽  
Miriam O Connor ◽  
Paula Calvert ◽  
...  
Keyword(s):  
Performance Status ◽  
Single Agent ◽  
Stage Iv ◽  
Stage Iii ◽  
Management Approach ◽  
Ageing Population ◽  
Single Institution ◽  
Co Morbidity ◽  
Stage Iv Disease ◽  
Clinical Tools

575 Background: The incidence of CRC increases with age. Future numbers are projected to rise due to an ageing population. Little data exists on chemotherapy in those ≥80 years (yrs) with CRC, a subgroup rarely included in clinical trials. The purpose of this study was to evaluate chemotherapy use, feasibility and tolerability in patients ≥80 yrs with CRC in a single institution. Methods: CRC diagnosed in those ≥80 yrs in a single institution in Ireland , from 2004 -2009, was determined. Clinicopathological data collected included age, gender, morphology, stage, and treatment including surgery, radiation or chemotherapy. In those receiving chemotherapy tolerance was determined by dose delays, reductions and number of completed cycles. Results: 83 cases of CRC were identified; 80-89 yrs (n=78), 90-100 yrs (n=5). Median age was 84 yrs (range 80-102), 38/83 (45.8%) were female. 59 cases of colon and 24 cases of rectal cancer were seen. Stage at diagnosis included IV (n=18), III (n=21), II (n=38) and I (n=6). For stage IV disease 4/18 (22%) received chemotherapy. Median overall survival for those with stage IV disease who received chemotherapy was 317 days (range 64-487) versus 169 days (range 30-473) for supportive care. 3/21(14%) stage III patients received chemotherapy. Median survival for stage III disease who received chemotherapy was 1193 days (range 432-1640) compared to 641 days who did not (range 0-1640). All patients with stage IV disease received single agent (SA) treatment (capecitabine n=3, cetuximab n=1). Treatment of stage III disease included: XELOX n=1, 5Fluorouracil/Leucovorin n=1, capecitabine n=1). 3/6 (50%) had dose reductions (n=4) and delays (n=7) in treatment. 1 patient completed scheduled adjuvant treatment. 1 patient with metastatic disease received second and third line treatment (SA irinotecan, cetuximab). Data including performance status, co morbidity will be presented. Conclusions: The uptake of chemotherapy in this cohort is low. Although the rates of treatment modifications are high, those treated appear to benefit. Better clinical tools are needed to differentiate those older patients likely to benefit from systemic therapy and those better served by supportive measures alone.

Does up-front definitive surgical resection with delayed chemotherapy in patients with stage IV rectal cancer compromise overall survival?

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 586-586
Author(s):  
Bindu V. Manyam ◽  
Shlomo A. Koyfman ◽  
Davendra Sohal ◽  
Ismail Mallick ◽  
Chandana A. Reddy ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Overall Survival ◽  
Surgical Resection ◽  
Proportional Hazards ◽  
Performance Status ◽  
Rectal Adenocarcinoma ◽  
Stage Iv ◽  
Cox Proportional Hazards ◽  
Significant Difference ◽  
Poorly Differentiated

586 Background: Definitive resection of the primary is frequently part of the management of patients (pts) with stage IV rectal cancer with good performance status and low volume of systemic metastases. It is unclear whether delaying systemic therapy for up front surgical management of the primary compromises overall survival (OS). Methods: Pts with metastatic rectal adenocarcinoma who received definitive surgical resection between 1998-2011 were identified in an IRB approved registry. The sequencing of CT and surgery, and the use of perioperative radiation therapy (RT), was at the discretion of treating physicians. Preoperative chemotherapy (Pre-CT) regimens included 5-fluorouracil (5-FU) +/- leukovorin (LV), capecitabine, 5-FU/LV/oxaliplatin +/- avastin, or 5-FU/LV/irinocetan. RT dose was typically 50.4 Gy. OS was measured from the date of diagnosis. Baseline variables were compared using the Chi-square and unpaired t-tests. OS was calculated using the Kaplan Meier method. Univariate (UVA) and multivariate analysis (MVA) were performed using Cox proportional hazards regression to identify variables associated with OS. Results: In this study of 115 pts, 75 (65%) were treated with pre-CT, while 40 (35%) were treated with up front surgery. Of the pts who received surgery up front, 3 (8%) received RT and of the pts who received pre-CT, 62 (83%) received RT. The cohort was predominantly male (70%) with a median age of 57, median KPS of 80, and median follow-up of 24.1 months. 94% of pts had T3/T4 tumors, 80% had N+ disease, and 33% had poorly differentiated tumors. Liver directed therapy (LDT) was performed in 61% of pts. There was no significant difference in OS (32.3 vs. 32 months; p = 0.24) between pts treated with pre-CT and those who received surgery up front, respectively. UVA demonstrated that pre-CT was not associated with OS (HR 1.26; p = 0.544). MVA demonstrated that pts with poorly differentiated tumors (HR 2.04; p = 0.007) and those that did not undergo LDT (HR 2.45; p = 0.001) had inferior survival. Conclusions: Delaying systemic chemotherapy in order to achieve local control with surgical resection up front does not appear to impact OS in pts with stage IV rectal cancer.

Neoadjuvant cytoreductive treatment with BRAF/MEK inhibition of prior unresectable regionally advanced melanoma to allow complete surgical resection: REDUCTOR trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9587-9587 ◽  
Author(s):  
Stephanie A. Blankenstein ◽  
Maartje W. Rohaan ◽  
W. Martin. C. Klop ◽  
Bernies Van Der Hiel ◽  
Bart A. Van De Wiel ◽  
...  
Keyword(s):  
Surgical Resection ◽  
Metabolic Response ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Stage Iv ◽  
Advanced Melanoma ◽  
Stage Iii ◽  
Advanced Stage ◽  
Pet Ct ◽  
Cytoreductive Treatment

9587 Background: The aim of this study is to evaluate the potency of short-term neoadjuvant cytoreductive therapy with dabrafenib and trametinib (BRAF and MEK inhibitor respectively) to allow radical surgical resection in patients with unresectable BRAF-mutated, locally advanced stage III or oligometastatic stage IV melanoma. Methods: A total of 25 patients with BRAF-mutated, unresectable locally advanced stage III or oligometastatic stage IV (≤3 metastases) melanoma will be treated with dabrafenib and trametinib for 8 weeks. Response evaluation by positron emission tomography/computed tomography (PET/CT) will occur at 2 and 8 weeks. If sufficient downsizing occurs, surgical resection will be performed. Biopsies for translational research will be taken at baseline and 2 weeks. The dissection specimen will be stored at 8 weeks. Results: Currently 20 patients have been included. Of these, 2 patients showed PD upon treatment and did not proceed to surgery. In 17/18 (94%) patients resection was possible after neoadjuvant treatment, of which 16 (94%) were R0 resections. Median follow-up time is 28 months with a median recurrence free survival of 9 months in patients undergoing surgery. The 1-year overall survival (OS) was 94% and 2-year OS 82%. Median OS was not reached. Metabolic response rates (RR) on PET/CT at 8 weeks were: 4 (20%) CR, 14 (70%) PR, 0 (0%) SD, 2 (10%) PD. Pathologic RR differed: 7 (35%) CR, 7 (35%) PR, 3 (15%) SD, 0 (0%) PD and in 3 patients (15%) no pathologic response was measured, since no resection was performed. Most patients (85%) experienced any toxicity, of which 50% was grade 1, 20% grade 2 and 3 patients (15%) experienced grade 3 toxicity. The most common reported toxicity was fever. Conclusions: Neoadjuvant dabrafenib and trametinib shows to be a potent cytoreductive treatment, allowing radical resection of metastases in 16/20 (80%) patients with prior unresectable locally advanced melanoma. Patients with no recurrence remained disease-free for a prolonged period of time. If there was recurrent disease, this usually occurred within months after surgery and this may present an opportunity for further tailored adjuvant therapy. Clinical trial information: NTR4654.

Predictors of survival in pancreatic squamous cell carcinoma (PSCC): An analysis from the National Cancer Database (NCDB).

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 399-399
Author(s):  
Anuhya Kommalapati ◽  
Sri Harsha Tella ◽  
Gaurav Goyal ◽  
Amit Mahipal
Keyword(s):  
Surgical Resection ◽  
Primary Tumor ◽  
Multivariable Analysis ◽  
Group Analysis ◽  
Stage Iv ◽  
The United States ◽  
Stage I ◽  
Stage Iii ◽  
Dismal Prognosis ◽  
Stage Iv Disease

399 Background: PSCC is a rare form of exocrine pancreatic malignancy with a dismal prognosis. Using the NCDB, we determined the prognostic factors and survival outcomes of PSCC in the United States. Methods: We performed a retrospective analysis of patients with histologically confirmed PSCC from 2004-2015 using NCDB. Kaplan-Meier method and log-rank test were used to perform overall survival (OS) analysis. Hazard Ratios were calculated using the Cox-proportional hazard method. Results: Of the 654 cases included in our analysis, 46% were female. Median age at diagnosis was 70 years and did not differ by sex (p = 0.19). The proportion of patients with stage I, II, III and IV diseases were 5%, 18%, 12%, and 54%, respectively (10%, unknown stage). Among these, 23% (35 of 150) of stage I and II disease, 10% (8 of 78) of stage III, and 2% (7 of 353) received surgical resection of the primary tumor. The rate of R0 resection was 74% in stage I and II; 38% in stage III; 29% in stage IV disease. Median OS for the entire cohort was 4 months and was significantly higher in patients who received surgical resection of the primary tumor (17 vs. 4 months, p < 0.001). On stage wise sub-group analysis, stage I-II patients had OS benefit from surgery (21 vs. 5 months, p < 0.001) as opposed to stage III (7 vs. 6 months, p = 0.31) and IV disease (5 vs. 3 months, p = 0.17). Adjuvant chemotherapy had no role in prolonging survival in stage I-II disease (20 vs 24 months, p = 0.6). Stage IV patients treated with chemotherapy had a better median OS than those without (5 vs. 2 months, p < 0.0001). On Cox multivariable analysis, stage IV disease (HR: 1.92 CI: 1.46-2.52, p < 0.001) and advanced patient age (HR: 1.02; CI:1.01-1.03, p < 0.001 were associated with poor OS, whereas OS was not dependent on the sex, race, grade, insurance status, surgery, and chemotherapy. Conclusions: This is the largest registry-based study on PSCC to date. PSCC had a diverse OS varied significantly according to increasing age and stage of the disease at presentation. Surgical resection of primary tumor was associated with improved OS in stages I-II, whereas chemotherapy improved OS in stage IV disease. The results of our study may aid the prognostication of patients and in treatment decision making.

scholarly journals The Effects of Radiation Therapy (RT) and Surgical Resection on Overall Survival in Gastric Lymphoma

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4415-4415
Author(s):  
Henry Vuong ◽  
Gurinder Sidhu ◽  
Vaibhav Verma
Keyword(s):  
Overall Survival ◽  
Native American ◽  
Surgical Resection ◽  
Gastric Lymphoma ◽  
Stage Iv ◽  
Stage I ◽  
Stage Iii ◽  
Asian Pacific Islander ◽  
Stage Iv Disease ◽  
Asian Pacific

Abstract Introduction: Lymphoma of the stomach is an uncommon tumor. However, it is the most common extra-nodal manifestation of Non-Hodgkin lymphoma. Over the last few decades, preferred treatment for gastric lymphoma has shifted from surgical resection to non-surgical methods involving chemotherapy and RT. The current standard treatment is chemo-immunotherapy. The role of RT and surgery, if any, is unclear. Methods: We reviewed data which was obtained from the Surveillance, Epidemiology and End Results (SEER) data registry for patients with gastric lymphoma from 1973 until 2011. The data was analyzed using Microsoft Excel and statistical analysis was performed using SPSS statistical software. The SEER registry does not provide information about chemotherapy (CT) administered. Results: We analyzed 13,659 patients with the diagnosis of gastric lymphoma in the SEER database. The three most prevalent subtypes were diffuse large B-cell lymphoma (DLBCL) with 6,134 (44.9%) cases, extranodal marginal zone lymphoma (MZL) with 4,318 (31.6%) cases and chronic lymphocytic leukemia (CLL/SLL) with 352 (2.5%) cases. In the DLBCL group, the median (range) age was 71 (4 – 105) years, of which 44.7% were female and 55.3% male. Of the group, 4,992 (81%) patients were White, 447 (7%) Black, and the remainder were Asian, Pacific Islander, or Native American. The median overall survival (OS) in patients who did and did not receive RT was 63 vs. 34 months (p<0.01). Analysis by stage shows median OS with and without RT was 108 vs. 65 months in Stage I disease (p<0.01), 71 vs. 62 months (p=0.41) in Stage II disease, 59 vs. 25 months in Stage III disease (p=0.52), and 8 vs. 8 months in Stage IV disease (p=0.46). The median OS in patients who underwent surgical resection, at least partial gastrectomy, is 76 months compared to 28 months in patients who did not undergo resection (p<0.01) (Fig.1). Analyzed by stage, the median OS in patients who did and who did not undergo surgery was 114 vs. 59 months in Stage I disease (p<0.01), 70 vs. 54 months in Stage II disease (p=0.03), 50 vs. 22 months in Stage III disease (p=0.63), and 10 vs. 8 months in Stage IV disease (p=0.85). Since widespread use of rituximab started in 2001, we analyzed patients treated before and after that year. Among patients with DLBCL, 2,719 (44%) were diagnosed prior to 2001 and 3,415 (56%) were diagnosed in 2001 or afterwards. Median OS with and without RT was 43 months vs. 31 months prior to 2001 and 97 months vs. 39 months after 2001 (p<0.01). The median OS with and without surgery is 81 vs. 12 months prior to 2001 (Fig. 2) and 57 vs. 51 months after 2001 (Fig. 3) (p<0.01). In the MZL group, the median (range) age was 68 (10 – 101) years of which 50.5% were female and 49.5% male. Of the group, 3,457 (80%) patients were White, 392 (9%) Black, and the remainder were Asian, Pacific Islander, or Native American. The median OS of patients with MZL who had surgery and who did not was 146 vs. 145 months (p=0.372). Analysis by stage shows no significance difference in OS either. The median OS of patients who did not undergo RT was 132 months and was not yet reached in patients who underwent RT (p<0.01). Analysis by stage shows RT significantly benefitted patients with Stage I and II disease but not stage III and IV disease. Conclusion: Our analysis shows that patients with DLBCL who undergo RT have improved median OS. The benefit is limited to Stage I disease. Improved median OS is seen in patients with DLBCL who undergo surgical resection which is contrary to recent data. The benefit of surgical resection is seen only in Stage I and II but not in Stage III and IV. The benefit of surgery was present prior to 2001 but not seen after 2001 - after the widespread use of rituximab. In MZL, surgical resection has no impact on median OS; whereas RT improves OS, particularly in Stage I and II disease. While our analysis is limited due to the lack of data regarding chemotherapy administered, this large population based analysis supports the benefit of RT and surgery in select disease stages. Prospective clinical trials may better address the benefits of each modality independently. Fig 1. KM Curve of DLBCL gastric lymphoma, all cases, who did and did not undergo surgery (p<0.01) Fig 1. KM Curve of DLBCL gastric lymphoma, all cases, who did and did not undergo surgery (p<0.01) Fig 2. KM Curve of DLBCL gastric lymphoma of cases diagnosed before 2001 (p<0.01) Fig 2. KM Curve of DLBCL gastric lymphoma of cases diagnosed before 2001 (p<0.01) Fig 3. KM Curve of DLBCL gastric lymphoma for cases diagnosed after 2001. Fig 3. KM Curve of DLBCL gastric lymphoma for cases diagnosed after 2001. Disclosures No relevant conflicts of interest to declare.

Stage III and stage IV non-small cell carcinoma patients triple chemotherapy combination (carboplatin, paclitaxel, and gemcitabine) in good performance status

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18205-18205
Author(s):  
R. T. Webb ◽  
L. M. Gill
Keyword(s):  
Performance Status ◽  
Stage Iv ◽  
Nonsmall Cell Lung Cancer ◽  
Drug Regimen ◽  
Stage Iii ◽  
Community Practice ◽  
Split Dose ◽  
Good Performance Status ◽  
Resistant Disease ◽  
Grade 3

18205 Background: Triple drug chemotherapy combinations for nonsmall cell lung cancer (NSCLC) have most recently begun to show promising results in regards to response rate and time to progression (TTP) of disease. This abstract presents data from 99 patients with advanced unresectable disease who were not felt to be candidates for concurrent radiation and chemotherapy for 1999 to 2005 treated with a split dose regimen of paclitaxel 65mg/m2 (d1, 8,15 q29 days), carboplatin AUC 2 (d1, 8,15 q29days), and gemcitabine 650 mb/m2 (d1, 8 or15 q29 days). All patients have completed a minimum of 3 courses of therapy. Methods: 57 males with mean age 72 years, and 42 females, mean age of 69 yrs with performance status of < 1. Stage III A&B-33 patients and Stage IV-56 patients. The regimen was well tolerated with 4% grade 3 to 4 neutropenia, 30% 2-to3 thrombocytopenia. There were no septic deaths, grade 3 to 4 nonhematologic toxicity included alopecia, universally, fatigue at 24% and emesis at 8%. Results: CR-14.4%, PR-31%, minimal/stable-26% with 27.6% progressive/resistant disease with a median survival time of 20.5 months. 37 patients did receive radiation therapy to the primary lesion. Conclusions: This 3-drug regimen administered in split dosing has proven to be highly active and well tolerated in good performance status patients seen in a community practice setting. This cohort of patients was representative and typical for the 85% of patients seen in community oncology practices. No significant financial relationships to disclose.

Phase II randomized trial of radiotherapy (RT), cetuximab (E), and pemetrexed (Pem) with or without bevacizumab (B) in locally advanced squamous cell carcinoma of the head and neck (SCCHN).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6043-6043 ◽  
Author(s):  
Athanassios Argiris ◽  
James Ohr ◽  
Greg J. Kubicek ◽  
Uma Duvvuri ◽  
Dwight Earl Heron ◽  
...  
Keyword(s):  
Phase Ii ◽  
Performance Status ◽  
Locally Advanced ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Median Number ◽  
Stage Iii ◽  
Community Practice ◽  
History Of ◽  
Grade 3

6043 Background: We previously developed a novel regimen by the addition of Pem to RT and E (Ann Oncol 2011;22:2482). The current study evaluated PemE in the phase II setting and assessed the addition of B, an anti-VEGF monoclonal antibody, to PemE based on promising data with Pem/B (JCO 2011;29:1140) and E/B (Ann Oncol 2013;24:200) in recurrent/metastatic SCCHN. Methods: Patients (pts) with previously untreated stage III/IV SCCHN of the oropharynx, larynx or hypopharynx, performance status (PS) 0-1, no history of bleeding, and adequate laboratory parameters were randomized after stratification for PS, stage and site to: RT 2 Gy/day to 70Gy, E 250mg/m2 weekly, after a loading dose of 400 mg/m2 1 week prior starting RT, and Pem 500mg/m2 every 21 days x 3 cycles (arm A, PemE), or the same regimen plus B 15mg/kg every 21 days x 3 cycles during RT followed by B maintenance x 8 cycles (arm B, B-PemE), with antibiotic prophylaxis. The primary endpoint was progression-free survival (PFS) with a target of 64% at 2 years; planned sample size was 80. Results: 79 pts were randomized of whom 77 were eligible and analyzable (arm A/B:36/41); oropharynx 65/larynx 12; HPV+ 38/HPV- 15/HPV unknown 24; stage IV 54/stage III 23. 31 pts were enrolled in community centers. Treatment delivery of E and Pem was similar between arms: E, median number of doses 8 (range, 5-11); Pem 3 (2-3); and B 3 (1-3). 5 deaths occurred: 3 due to progression; 1 from unknown cause; 1 pt died from hemoptysis after bronchoscopy within 4 weeks of the 8th cycle of B leading to elimination of B maintenance after the 6th pt was enrolled. 9 pts (2 HPV+) progressed. With a median follow-up of 18 months, the 2-year PFS was 81% vs 87% and the 2-year overall survival (OS) was 96% vs 86% for arm A vs B. Grade 3/4 acute toxicities for arm A vs B (N=59) : dermatitis 3/1 vs 4/1; mucositis 13/2 vs 13/0; neutropenia 7/4 vs 7/3; rash 6/1 vs 8/1; fatigue 1/0 vs 3/0; weight loss 2/0 vs 5/0. Conclusions: Both regimens are feasible in academic and community practice settings with expected toxicities. Preliminary efficacy results are very promising and better than projected, however, the addition of B does not appear to improve outcomes. Clinical trial information: NCT00703976.

Real-world characteristics and outcomes of patients with advanced non-small cell lung cancer (aNSCLC) receiving immune checkpoint inhibitor.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9110-9110
Author(s):  
Sean Khozin ◽  
Jizu Zhi ◽  
Monika Jun ◽  
Li Chen ◽  
Wendy S. Rubinstein ◽  
...  
Keyword(s):  
Real World ◽  
Immune Checkpoint ◽  
Checkpoint Inhibitors ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Local Therapy ◽  
Stage Iv ◽  
Stage Iii ◽  
Ecog Performance Status ◽  
The Real

9110 Background: Immune Checkpoint Inhibitors (ICIs) were first approved for the treatment of aNSCLC in 2014, and since this time have seen rapid adoption in the marketplace. We sought to describe the characteristics of patients with aNSCLC receiving ICIs in the real-world, as well as to examine treatment patterns and outcomes in the time since initial ICI approval. Methods: We conducted a retrospective, observational cohort study using statistically de-identified data from January 2011 to November 2018 in CancerLinQ, ASCO’s real-world oncology database. Adult patients with a curated diagnosis of Stage III or IV NSCLC who received ≥1 dose of an ICI and had ≥2 clinical visits were eligible for inclusion. Stage III patients were excluded if they received any local therapy < 1 year prior to receiving ICI. Patients were also excluded if they received ICI prior to the first FDA approval date. Demographic and clinical characteristics of aNSCLC patients receiving ICI are reported. Outcomes including time to treatment discontinuation (TTD), time to next treatment (TTNT), real-world progression free survival (rwPFS) and overall survival (OS) were examined via the Kaplan Meier method. Results: Among 2,425 aNSCLC ICI patients included in this analysis, median age was 68.0 years (IQR 60.7, 75.2], 54% were male and 73% of patients were white. Non-squamous histology accounted for 64% of aNSCLC ICI users, and 81% had Stage IV disease. Eastern Cooperative Oncology Group (ECOG) performance status was 0-1 in 77% and 2+ in 23% of patients, and 70% were current or former smokers. The majority (75%) of patients received ICI as second-line or later therapy. Treatment outcomes and survival are reported in the Table. Conclusions: This analysis demonstrates that aNSCLC patients receiving ICI therapy in the real-world are older than what was reported in some clinical trials, though survival outcomes were similar. Further research to examine impact of covariates on outcomes is warranted. [Table: see text]

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