scholarly journals Primary mFOLFOX6 Plus Bevacizumab Without Resection of the Primary Tumor for Patients Presenting With Surgically Unresectable Metastatic Colon Cancer and an Intact Asymptomatic Colon Cancer: Definitive Analysis of NSABP Trial C-10

2012 ◽  
Vol 30 (26) ◽  
pp. 3223-3228 ◽  
Author(s):  
Laurence E. McCahill ◽  
Greg Yothers ◽  
Saima Sharif ◽  
Nicholas J. Petrelli ◽  
Lily Lau Lai ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Surgical Resection ◽  
Primary Tumor ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Morbidity Rate ◽  
Metastatic Colon Cancer ◽  
Major Morbidity ◽  
End Point

Purpose Major concerns surround combining chemotherapy with bevacizumab in patients with colon cancer presenting with an asymptomatic intact primary tumor (IPT) and synchronous yet unresectable metastatic disease. Surgical resection of asymptomatic IPT is controversial. Patients and Methods Eligibility for this prospective, multicenter phase II trial included Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1, asymptomatic IPT, and unresectable metastases. All received infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) combined with bevacizumab. The primary end point was major morbidity events, defined as surgical resection because of symptoms at or death related to the IPT. A 25% major morbidity rate was considered acceptable. Secondary end points included overall survival (OS) and minor morbidity related to IPT requiring hospitalization, transfusion, or nonsurgical intervention. Results Ninety patients registered between March 2006 and June 2009: 86 were eligible with follow-up, median age was 58 years, and 52% were female. Median follow-up was 20.7 months. There were 12 patients (14%) with major morbidity related to IPT: 10 required surgery (eight, obstruction; one, perforation; and one, abdominal pain), and two patients died. The 24-month cumulative incidence of major morbidity was 16.3% (95% CI, 7.6% to 25.1%). Eleven IPTs were resected without a morbidity event: eight for attempted cure and three for other reasons. Two patients had minor morbidity events only: one hospitalization and one nonsurgical intervention. Median OS was 19.9 months (95% CI, 15.0 to 27.2 months). Conclusion This trial met its primary end point. Combining mFOLFOX6 with bevacizumab did not result in an unacceptable rate of obstruction, perforation, bleeding, or death related to IPT. Survival was not compromised. These patients can be spared initial noncurative resection of their asymptomatic IPT.

A phase II trial of 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) chemotherapy plus bevacizumab (bev) for patients (pts) with unresectable stage IV colon cancer and a synchronous asymptomatic primary tumor: Updated results of NSABP C-10 with definitive survival analysis.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 468-468 ◽  
Author(s):  
Laurence E. McCahill ◽  
Greg Yothers ◽  
Saima Sharif ◽  
Nicholas J. Petrelli ◽  
Samia H. Lopa ◽  
...  
Keyword(s):  
Surgical Resection ◽  
Primary Endpoint ◽  
Primary Tumor ◽  
Interventional Procedure ◽  
Distant Metastases ◽  
Morbidity Rate ◽  
Colon Tumor ◽  
Major Morbidity ◽  
Primary Colon

468 Background: Surgical resection of asymptomatic primary colon tumor for pts presenting with synchronous yet unresectable metastatic disease is controversial. We published results for the primary endpoint in JCO in September 2012. Here we update the primary endpoint and present definitive survival results. Methods: Eligible pts had ECOG Performance 0 or 1, an asymptomatic colon tumor and unresectable distant metastases. Primary endpoint (PE) was major morbidity, defined as surgical resection or death related to the intact primary tumor. Major morbidity rate of 25% was considered acceptable and the trial had 85% power to rule out a rate of 40%. Secondary endpoints were overall survival and morbidity related to the intact primary requiring hospitalization, transfusion, or interventional procedure. Results: Between March 2006-June 2009, 90 pts were registered and 86 eligible pts with follow-up comprise this analysis. 52% were female and 47% were age 60+. Median follow-up was 61.5 mos. There were 15 (17.4%) major morbidity events, 12 (14.0%) required surgery: obstruction (9), perforation (2), and pain (1). Three (3.5%) resulted in pt death: perforation (2), obstruction (1). Cumulative incidence of major morbidity at 42 mos was 17.7% (95% CI 9.5-26.0%). Fourteen other primary tumor resections were performed: attempted cure (11), other reasons (3). There were 6 secondary endpoint events: 4 obstructions (2 required stents, 2 resolved with conservative management), 2 pts with suspected perforation required percutaneous drainage (1) and hospitalization and antibiotics (1). Median survival was 18.3 mos (95% CI 15.2-24.2). Two year OS rate was 38.7% and 3 year OS rate was 15.1%. Conclusions: The primary endpoint holds with the updated analysis justifying observation for asymptomatic primary colon cancers even in patients with a good clinical response of distant metastases. Clinical trial information: NCT 00321828.

Role of Up-Front Primary Tumor Resection and Tumor Sidedness in the Survival of Synchronous Metastatic Colon Cancer Patients

2021 ◽  
pp. 1-7
Author(s):  
Dave E.W. van der Kruijssen ◽  
Karlijn L. van Rooijen ◽  
Sophie A. Kurk ◽  
Johannes H.W. de Wilt ◽  
Cornelis J.A. Punt ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Confidence Interval ◽  
Primary Tumor ◽  
Cox Regression ◽  
Performance Status ◽  
Tumor Resection ◽  
Serum Lactate ◽  
Primary Tumor Resection ◽  
Serum Lactate Dehydrogenase ◽  
Metastatic Colon Cancer

<b><i>Introduction:</i></b> Uncertainty exists about a possible survival benefit of primary tumor resection (PTR) in synchronous metastatic colon cancer (mCC). Since sidedness of the primary tumor is regarded as an important prognostic factor, our objective was to study the interaction between PTR and sidedness in synchronous mCC. <b><i>Methods:</i></b> In this retrospective study, we used data from 2 first-line phase 3 randomized controlled trials (RCTs). A mixed Cox regression model was used to study the multiplicative interaction between PTR and sidedness. We adjusted for age, treatment arm, WHO performance status, number of affected organs by metastases, serum lactate dehydrogenase, and year of enrollment. <b><i>Results:</i></b> We found that PTR is associated with better survival in both right-sided (hazard ratio [HR] 0.59 [95% confidence interval 0.42–0.8 2]) and left-sided mCC (HR 0.70 [95% confidence interval 0.52–0.93]). The interaction between PTR and sidedness was not significant (<i>p</i> = 0.45). <b><i>Conclusion:</i></b> Our data suggest that the prognostic value of PTR is independent of sidedness. Validation of these results will be performed in ongoing RCTs.

Two case reports of rare diseases occurring in rare parts: Splenic vein solitary fibrous tumor and Liver solitary fibrous tumor

2020 ◽  
Author(s):  
Wenjing Wang ◽  
Banghe Bao ◽  
Anbin Hu ◽  
Xiaofeng Zhu ◽  
Qing Chen
Keyword(s):  
Liver Transplantation ◽  
Surgical Resection ◽  
Orthotopic Liver Transplantation ◽  
Solitary Fibrous Tumor ◽  
Primary Tumor ◽  
Splenic Vein ◽  
Tumor Site ◽  
Primary Tumor Site ◽  
Fibrous Tumor

Abstract Background Solitary fibrous tumor (SFT) is a rare soft tissue tumor originating from mesenchyme. Two cases of SFT we report right now occurred in the splenic vein and liver respectively, this primary splenic vein SFT may be the first report case, and also the first report of liver recurrence SFT cured by orthotopic liver transplantation (OLT). Case presentation One case was a 37-year-old female patient whose primary tumor site was located in the splenic vein, which resulted in splenomegaly and hypersplenism; its recurrence again and again after surgical resection and eventually transferred to the liver, during 10 years of follow-up, 4 operations were performed, and he is in a good condition right now. The second case was a 54-year-old male patient whose primary tumor site was located in the liver, spleen and left side of the chest wall; however, he had no uncomfortable symptoms. Surgeons performed two operations to remove these tumors, totally. 6 years later, SFT recurrence in the liver, and given that the tumor was so large that it could not be completely surgical resected, we chose orthotopic liver transplantation (OLT), and no tumor recurrence during 12-month follow-up. Conclusion The reports of these two cases of SFT are very rare, especially the splenic vein SFT, which expand the understanding of SFT. The main treatment of SFT is still surgical resection, right now, and liver transplantation may be a new option treatment for the huge liver SFT.

Irinotecan during pregnancy in metastatic colon cancer

2012 ◽  
Vol 98 (6) ◽  
pp. e155-e157 ◽  
Author(s):  
Massimo Cirillo ◽  
Mariella Musola ◽  
Paola Agnese Cassandrini ◽  
Gianluigi Lunardi ◽  
Marco Venturini
Keyword(s):  
Colon Cancer ◽  
Gestational Age ◽  
Case Reports ◽  
Therapeutic Option ◽  
Male Infant ◽  
Colon Resection ◽  
Metastatic Colon Cancer ◽  
Emergency Cesarean ◽  
Node Metastases

Background Colon cancer during pregnancy is a relatively rare occurrence. To date there has been sparse clinical evidence about the safety of chemotherapy in this setting because the available data derive only from single-institution case reports. Methods Irinotecan and fluorouracil, as part of the FOLFIRI regimen, were administered to a 33-year-old pregnant woman at an estimated gestational age of 23+ weeks. She had been diagnosed with adenocarcinoma of the transverse colon with liver and lymph node metastases. Results Chemotherapy was administered from the 23+th to the 28+th week of gestational age. Chemotherapy was stopped because of disease progression. At 30 weeks' gestational age, the patient underwent an emergency cesarean section and colon resection. She gave birth to a healthy male infant with no particular problems in neurological, respiratory, cardiovascular, digestive and nutritional function. At follow-up, the 13-month-old child had achieved all appropriate growth and developmental milestones. Conclusions Our report demonstrates the safety of exposure to FOLFIRI for both mother and fetus. The absence of any abnormalities in the infant makes irinotecan and fluorouracil a valid therapeutic option for colon cancer during pregnancy.

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