Kras mutation as a risk factor for venous thromboembolism in patients with metastatic pancreatic cancer.

e16267 Background: Venous thromboembolism (VTE) is a common complication in oncology patients. It has been reported that VTE increases morbidity and mortality in these patients. It’s prevalence in metastatic pancreatic cancer (mPC) ranges around 4-7.5% Preclinic studies suggest that the mutation of the KRAS oncogene (KRASm) is associated with a higher risk of VTE among patients with colorectal cancer. KRASm appears to increase the expression of tissue factor, a physiological trigger of coagulation that is found on the surface of tumor cells. This association has not been studied in mPC, where this mutation can be found in 90% of the cases. Our aim is to determine the prevalence and risk factors associated with VTE taking into consideration the status of KRAS. Methods: We conducted a retrospective study within a cohort of patients with mPC that had a determination of the KRAS status. These patients were treated at Medical Oncology between January 2017 and December 2020. We performed a descriptive and survival analysis of our sample. We also studied the prevalence of VTE among the. Results: Our study cohort was 88 patients (pts), 63 (61, 2%) men and 40 (38, 8%) women. The median age was 63 years (32-84). 19 pts (18, 4%) were KRAS wild type (KRASwt), 69 pts (67%) KRASm. There was no statistically significant difference in gender, age, performance status, comorbidities, primary tumor/metastases location, disease control rate and toxicity between KRASwt and KRASm. Median serum levels of Ca 19.9 were higher in KRASm (39.847 U/ml vs 2026 U/ml). At the time of diagnosis, 78 pts (88, 6%) were metastatic and 10 pts (11, 4%) were localized/locally-advanced. Most of metastatic pts (62/78) were KRASm (p = 0, 015). Most common histology (86, 4%) was adenocarcinoma. This histology was more frequent in KRASm, 61, 8% (p = 0, 02). At time of analysis, 72 pts (69, 9%) were dead, most of them (54, 4%) were KRASm (p = 0, 001). 31 pts developed VTE: 4 were KRASwt and 27 KRASm. The prevalence of VTE was 36, 3%. It was greater in KRASm (39, 1%) than in KRASwt (26, 3%). There were 7 cases of rethrombosis instead of anticoagulant treatment (1 KRASwt and 6 KRASm). KRASwt seems to be a protective factor in the development of VTE (OR 0, 55; CI 95% 0, 18-1, 71). The most common entity were VTE of splenoportomensenteric axis (16 pts), followed by pulmonary embolism, EP, (7 pts), deep venous thrombosis, DVT, (4 pts) EP + DVP (3 pts), thrombosis associated with central venous catheter (3 pts) and other locations (2 pts). There were no differences in VTE location between KRASwt and KRASm. The median overall survival (OS) was 12, 82 months (CI 95%: 7, 87-17, 78). It was higher in KRASwt (26 months; CI 95%: 12, 21-40, 48) than in KRASm (9, 8 months; CI 95%: 6, 07-13, 65). This difference was statistically significant (p = 0, 001). Conclusions: In our cohort, the prevalence of VTE is higher than de prevalence described in the literature and was greater in KRASm population. OS was significantly larger in KRASwt.

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A phase III trial of virulizin plus gemcitabine vs. gemcitabine alone in advanced pancreatic cancer: Results of subgroup analysis

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.4116 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 4116-4116 ◽

Cited By ~ 3

Author(s):

J. A. Wright ◽

J. Osterlee ◽

S. Fekete ◽

Y. Lee ◽

A. H. Young

Keyword(s):

Pancreatic Cancer ◽

Metastatic Cancer ◽

Performance Status ◽

Locally Advanced ◽

Advanced Pancreatic Cancer ◽

Phase Iii ◽

Double Blind ◽

Significant Difference ◽

Ecog Ps ◽

To Receive

4116 Background: Virulizin (V) is a novel antitumor immune modulator that improves survival in pancreatic cancer patients (pts) as monotherapy. A double-blind, multicenter, randomized, phase III study was conducted to evaluate the survival benefits and safety of V in combination with gemcitabine (G) in pts with advanced pancreatic cancer. Methods: Chemo-naive pts with locally advanced or metastatic pancreatic cancer with ECOG Performance Status (PS) of 0, 1 or 2 were enrolled. Pts were randomized to receive intramuscular injections of either V or placebo (P) 3 times weekly + G (1,000 mg/m2 weekly ×7 with 1 week rest, then weekly ×3 q4w). Randomization was stratified according to ECOG PS (0 or 1, and 2) and extent of disease (locally advanced and metastatic). Pts who showed no clinical benefit or were intolerant to G entered 2nd-line therapy (stage 3), in which pts continued to receive either V or P alone or with 5-FU, or best supportive care. The primary endpoint was survival, defined as time from baseline/treatment day 1 to time of death from any cause. Results: The intent to treat (ITT) population comprised 434 pts, of which 377 were efficacy evaluable (EE). Median overall survival for V + G was 6.3 months for the ITT population (6.8 months for EE pts) and 6 months for P + G for both ITT and EE pts. While differences in survival times were not statistically significant, exploratory analysis showed encouraging results in specific subgroups treated with V + G ( table ). Importantly, a significant difference was found in stage 3 pts who received V in a salvage setting compared to pts who received P. Conclusions: Pancreatic cancer pts with either low ECOG PS or metastatic cancer showed a survival benefit when treated with V + G, which was significant in pts who continued to receive V as a salvage therapy. Further studies in these targeted patient populations are being considered. [Table: see text] No significant financial relationships to disclose.

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Safety and efficacy of modified FOLFIRINOX in pancreatic cancer: A retrospective experience.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e14614 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e14614-e14614 ◽

Cited By ~ 4

Author(s):

Hemchandra Mahaseth ◽

John S. Kauh ◽

Edith Brutcher ◽

Natalyn Nicole Hawk ◽

Sungjin Kim ◽

...

Keyword(s):

Pancreatic Cancer ◽

Performance Status ◽

Single Agent ◽

Locally Advanced ◽

Progression Free Survival ◽

Metastatic Pancreatic Cancer ◽

Clinical Activity ◽

Ecog Performance Status ◽

Emory University ◽

Grade 3

e14614 Background: Conroy et al reported a significant improvement in overall survival of patients with metastatic pancreatic cancer treated with FOLFIRINOX compared to single agent gemcitabine. The regimen was associated with significant grade 3/ 4 toxicities, such as myelosuppression(46%), fatigue(24%), vomiting(15%) and diarrhea (13%). In order to improve the toxicity profile, we have modified FOLFIRINOX (mFOLFIRINOX) regimen by removing the bolus 5-FU and adding the routine use of growth factor prophylaxis. We present our experience with mFOLFIRINOX in patients with locally advanced or metastatic pancreatic cancer. Methods: After obtaining IRB approval, patients with a diagnosis of pancreatic cancer were identified from the Emory University tumor registry. Twenty eight patients who received at least one dose of mFOLFIRINOX (5-FU 2400 mg/m2 CIVI over 46 hours, leucovorin 400 mg/m2, oxaliplatin 85 mg/m2, irinotecan 180 mg/m2 and pegfilgrastim 6 mg every two weeks ) were selected and their charts were retrospectively reviewed for safety, response, and survival. Results: Of 28 patients, 14 (50%) were male, 18 (64%) white, 8 (29%) black and other 2(7%). Median age was 63 (50-75) and ECOG performance status 0-1. Nineteen (68%) patients had primary tumor located in head of pancreas. Eight patients (29%) experienced grade 3/4 toxicities, i.e., nausea/vomiting (11%), diarrhea (11%), fatigue (11%), neuropathy (4%), neutropenia (4%), thrombocytopenia(4%), and sepsis not-related to neutropenia (4%). No grade 3/4 anemia or febrile neutropenia was noted. mFOLFIRINOX controlled the disease in 20 patients (71%) with 2 CR, 4 PR and 14 SD. With a median follow up of 5.5 months, median overall or progression free survival is not reached. Two patients have died and six patients have progressed. Conclusions: Modified FOLFIRINOX is well tolerated in this US population. The clinical activity appears very promising with majority of patients being free of progression.

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A randomized phase II clinical trial of gemcitabine, oxaliplatin, erlotinib combination chemotherapy versus gemcitabine and erlotinib in previously untreated patients with locally advanced or metastatic pancreatic cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.4_suppl.344 ◽

2018 ◽

Vol 36 (4_suppl) ◽

pp. 344-344 ◽

Cited By ~ 1

Author(s):

Sung Hee Lim ◽

Jina Yun ◽

Min-Young Lee ◽

Han Jo Kim ◽

Kyoung Ha Kim ◽

...

Keyword(s):

Pancreatic Cancer ◽

Response Rate ◽

Locally Advanced ◽

Progression Free Survival ◽

Metastatic Pancreatic Cancer ◽

Overall Response ◽

Significant Difference ◽

Common Grade ◽

Secondary Endpoints ◽

Grade 3

344 Background: Erlotinib is the only targeted agent in combination with gemcitabine showing significantly improved outcomes in pancreatic cancer. Although combining platinum agent with gemcitabine has not provided clear survival benefit over gemcitabine alone, gemcitabine plus platinum resulted in improved response rate and progression-free survival (PFS). We tried to evaluate whether the addition of oxaliplatin to gemcitabine/erlotinib confers a clinical benefit to patients with locally advanced or metastatic pancreatic cancer. Methods: Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned to receive GEMOX-T (gemcitabine 1000mg/m2 IV and oxaliplatin 50mg/m2 IV on day 1, 8 plus erlotinib 100mg daily, every 3weeks) or GT (gemcitabine 1000mg/m2 IV on day 1, 8 plus erlotinib 100mg daily, every 3weeks). The primary endpoint was overall response and secondary endpoints included PFS, overall survival (OS) and toxicity. Results: Between May 2013 and April 2016, 65 patients were randomly assigned to treatment group (33 in GEMOX-T arm, 32 in GT arm). The median age of all patients was 61 years (range, 41-76) and about 80% of patients had metastatic disease. The overall response rate was 18.2 % in GEMOX-T arm and 6.2% in GT arm ( P = 0.051). The disease control rate was significantly superior in GEMOX-T arm compared to GT arm (72.7% vs. 43.8%, P = 0.019), with 1 patient in GEMOX-T group continuing the treatment with stable disease. After a median follow up of 19.7 months, there was significant difference in PFS: the median PFS were 3.9 months for GEMOX-T arm and 1.4 months for GT arm (Hazard ratio: 0.58, 95% CI 0.35-0.96, P = 0.037). However, it did not translate to improvement of OS (median OS; 6.2 m for GEMOX-T arm, 5.1 m for GT arm, P = 0.118). The most common grade ≥ 3 hematologic adverse events were neutropenia (16.9%) and anemia (13.8%). Conclusions: The addition of oxaliplatin to 1st line gemcitabine/erlotinib regimen demonstrated higher response rate and significantly improved PFS in patients with locally advanced or metastatic pancreatic cancer.

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FOLFIRINOX for advanced pancreatic cancer: The Princess Margaret experience.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.417 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 417-417 ◽

Cited By ~ 1

Author(s):

Muralidharan Chllamma ◽

Natalie Cook ◽

Kazim Giby ◽

Anna Dodd ◽

Lisa Wang ◽

...

Keyword(s):

Pancreatic Cancer ◽

Performance Status ◽

Locally Advanced ◽

Advanced Pancreatic Cancer ◽

Pancreatic Head ◽

Validated Questionnaire ◽

Significant Difference ◽

Starting Dose ◽

Grade 3 ◽

Dose Reductions

417 Background: The FOLFIRINOX regimen has been shown to significantly increase both overall (OS) and progression free (PFS) survival in metastatic pancreas cancer (MPC), albeit with an increase in adverse events (AEs). It is not known whether initial dose reductions compromise FOLFIRINOX efficacy and there are limited data regarding treatment of locally advanced pancreatic cancer (LAPC). Methods: We conducted a retrospective review of patients (pts) treated with FOLFIRINOX for MPC or LAPC at Princess Margaret Cancer Centre, and began treatment between Dec 2011 and April 2014. The primary objective was to evaluate the efficacy and safety of FOLFIRINOX when used with dose modifications. Results: 102 pts were identified; 66 MPC and 36 LAPC. Median age was 65 years. 72% of pts had pancreatic head tumors. At baseline 95% of pts had an ECOG performance status of 0 or 1; 95% had bilirubin < 1.5 ULN and 45% had a biliary stent. 68% of pts initiated treatment with a dose reduction (93% reduction or omission of bolus 5FU, 88% reduction in Irinotecan, 68% reduction in Oxaliplatin and 66% reduction in infusional 5FU). Median number of cycles was 6 (1-31); 25% of pts received <4 cycles. Median OS in metastatic pts was 12.9 months (mo) and 23 mo in LAPC; Median PFS was 8.7 mo (metastatic) and 11.1 mo in LAPC. There was no significant difference in PFS (10.9 vs. 10.3 mo; p=0.60) or OS (11.1 vs. 14.0 mo; p=0.19) between the full starting dose and reduced starting dose groups respectively. Partial response or stable disease was achieved in 57% of pts; 11% of the LAPC pts had a surgical resection. Grade 3/4 hematologic AEs were observed in 43% of pts (febrile neutropenia in 6%). Only 13% of pts received G-CSF support. Grade 3/4 non-hematologic AEs were observed in 28% of pts, including vomiting (19%), nausea (16%) and diarrhea (16%). 18% of pts had a treatment related hospitalization (5% neutropenic sepsis, 13% GI toxicity/dehydration.) There was one treatment related death. Pt wellbeing (scored on a validated questionnaire) significantly improved from baseline to cycle 4 (p=0.002). Conclusions: Modest dose reductions do not appear to compromise efficacy of FOLFIRINOX. Our median PFS, OS and AEs are comparable to other studies using FOLFIRINOX in both LAPC and metastatic disease.

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Phase two clinical trial of combination oxaliplatin, irinotecan, and cetuximab for patients with locally advanced or metastatic pancreatic cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e15781 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e15781-e15781 ◽

Cited By ~ 1

Author(s):

Yara Abdou ◽

Sarah Cooke Friend ◽

Yehuda Z. Patt ◽

Christine Gan ◽

Fa-Chyi Lee

Keyword(s):

Pancreatic Cancer ◽

Clinical Trial ◽

Disease Control ◽

Performance Status ◽

Objective Response ◽

Locally Advanced ◽

Advanced Pancreatic Cancer ◽

Disease Control Rate ◽

Metastatic Pancreatic Cancer ◽

Combination Regimen

e15781 Background: Pancreatic cancer remains a leading cause of cancer death with limited treatment options. After promising results from a retrospective chart review of the combination of irinotecan, oxaliplatin, and cetuximab (OIC), a prospective phase II trial was conducted to determine the efficacy and safety of this novel combination regimen in patients with advanced pancreatic cancer. Methods: Patients aged 18 and older, with a performance status of 0-2, and a life expectancy of minimum 12 weeks were eligible if they had confirmed locally advanced or metastatic pancreatic cancer. Patients were treated with intravenous irinotecan at 90 mg/m2, oxaliplatin at 60 mg/m2, and cetuximab at 250 mg/m2on day 1 of a 14-day cycle. Treatment was continued until disease progression or unacceptable toxicity. The primary efficacy endpoint was objective response rate (ORR) and disease control rate (DCR) per RECIST 1.1 criteria. The secondary endpoints included progression free survival (PFS), overall survival (OS), and tolerability of the regimen. Results: 60 patients were enrolled and 58 were evaluable; of these, 78% had metastatic disease and 22% had locally advanced cancer at time of enrollment. 41.4% of patients had received at least one prior line of cytotoxic chemotherapy. The ORR and DCR were 6.9% and 58.6%, respectively (complete response n = 1; partial response, n = 3; stable disease, n = 30). The median PFS was 3.6 months [95 % confidence interval (CI): 2.24-4.31], and median OS was 4.8 months [95 % CI: 3.68-6.25]. The most common grade 3 or 4 toxicities were hypokalemia (20.7%), fatigue (17.2%), abdominal pain (15.5%), hyperglycemia (13.8%) and dehydration (13.8%). Conclusions: OIC on a two-week regimen was well tolerated and demonstrated a high disease control rate, encouraging further investigation of this regimen in advanced pancreatic cancer. Clinical trial information: NCT00871169.

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Impact of KRAS mutations in clinical features and survival in pancreatic cancer patients: A single institution experience.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e15779 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e15779-e15779

Author(s):

Elizabeth Inga Saavedra ◽

Maria Auxiliadora Gomez ◽

Maria Teresa Cano ◽

Eduardo Perdomo ◽

Marta Toledano ◽

...

Keyword(s):

Pancreatic Cancer ◽

Clinical Features ◽

Cox Regression ◽

Locally Advanced ◽

Real Life ◽

Categorical Variables ◽

Study Cohort ◽

Kras Mutations ◽

Significant Difference ◽

The Impact

e15779 Background: Pancreatic cancer (PC) is currently one of the most lethal tumors. In recent years, although improvements have been developed in the detection and treatment of this disease, the 5-year survival is less than 10%. KRAS plays a key role in ras/mitogen-activated protein kinase signaling. Somatic mutation in KRAS mutations have been shown to be early events in the carcinogenesis of PC. KRAS mutations as a prognostic factor for PC remains inconclusive. Methods: We performed a retrospective study of our patients (pts) to demonstrate the impact of KRAS mutations in clinical features and survival in real-life clinical practice. This was an observational study of all patients with histological confirmed PC referred to Medical Oncology between April 2017 to December 2018 and followed until February 2019. KRAS mutations were analyzed by sequencing codons 12, 13, and 61 in diagnostic tumor tissues from formalin fixed paraffin embedded tissue using PCR and liquid biopsy test (BEAMing technology). Categorical variables were statistically analyzed with Fisher’s exact test and continuous variables with T-student for differences between both groups. Survival was analyzed by Kaplan–Meier estimation and log-rank testing while Cox regression was used to estimed hazard ratios. Results: Our study cohort was 64 pts. 43% of pts died, the most die at home (25%). Median follow-up was 552 days (18 months). Metastatic pts had an expected overall survival (OS) of 376 days, locally advanced 525 days and localized stage 592 days but not statistically significant difference (p = 0.11). Wild-type pts had an expected OS of 559 days and KRAS mutated 389 days with statistically significant difference. (p = 0.032). Conclusions: KRAS mutations are associated with a poorer survival in patients with pancreatic cancer in all stages. These results suggest that KRAS mutations may be an important biomarker in determining response and prognosis in patients with high risk and in developing specific treatments for these patients in clinical applications.[Table: see text]

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Efficacy of Chemotherapy for Locally Advanced and Metastatic Pancreatic Cancer: A real life experience and outcome from a tertiary referral centre.

Journal of Cancer & Allied Specialties ◽

10.37029/jcas.v7i2.409 ◽

2021 ◽

Vol 7 (2) ◽

Author(s):

Samia Yasmeen ◽

Sabah Shaukat ◽

Farah Arshad ◽

Farhana Badar ◽

Syed Ather Saeed Kazmi ◽

...

Keyword(s):

Pancreatic Cancer ◽

Overall Survival ◽

Response Rate ◽

Chemotherapy Regimen ◽

Locally Advanced ◽

Advanced Pancreatic Cancer ◽

Progression Free Survival ◽

Metastatic Pancreatic Cancer ◽

Free Survival ◽

Significant Difference

Introduction: To report response rate, progression-free survival and overall survival in patients with advanced pancreatic cancer treated with different available chemotherapeutic regimens over ten years. Materials and Methods: This is a retrospective observational study. All patients with locally advanced and metastatic pancreatic cancer at Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan, from January 2008 to December 2017 were studied. Data were collected from the hospital information system. The characteristics and outcomes of all the patients were analyzed. Progression-free survival and overall survival were also estimated. Kaplan Meier curves and Log-rank test were applied, and SPSS version 20 was used for data analysis. Results: Eighty-seven (87) subjects with a median age of 56 years (range 21-76) were included. Sixty-two (71%) subjects were male. The most common tumor location was the head of the pancreas in 46(53%) of all the subjects. Sixty-three (72%) subjects had elevated CA-19.9 values. About 47(54%) subjects had locally advanced pancreatic cancer (LAPC), and 40(46%) subjects had metastatic pancreatic cancer (MPC). Chemotherapy regimens used were FOLFIRINOX in 23(26%), gemcitabine-based 66(65%) and capecitabine-based in 8 (9%) of the subjects. One (1%) subject had a complete response (CR), 12(14%) had a partial response (PR), 10 (11%) had stable disease, and 59(68%) of the subjects had progressive disease (PD). The objective response rate (ORR) was 15%, and the disease control rate (DCR) was 26%. In MPC, the ORR was 10%, DCR was 18%, and tumor progression was seen in 72% of the patients, while in LAPC, the ORR was 19.1, DCR 34% and tumor progression was documented in 64% of the patients, respectively. The FOLFIRNOX chemotherapy regimen had better ORR, DCR and lesser number of progressions as compared to Gemcitabine and Capecitabine based chemotherapy regimens. The Median PFS of the whole group was 32-weeks, and the median OS was 54-weeks. The PFS was significantly higher for LAPC (39 weeks) as compared to the MPC group (25 weeks) (p=0.028). There was no statistically significant difference between the OS of these 2 groups (p=0.451). In addition, PFS was significantly higher with FOLFIRINOX chemotherapy as compared to the other chemotherapy regimens. Regarding OS, there was no statistically significant difference among all chemotherapy regimen groups (p=0.267). Conclusion: Based on our results, FOLFIRINOX remained the most effective chemotherapy regimen despite the dose modifications and toxicities in all groups, indicating that modified FOLFIRINOX could be considered as a first-line regimen in south East Asian population.

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Concurrent high-dose intensity-modulated radiotherapy and chemotherapy for unresectable locally advanced and metastatic pancreatic cancer: a pilot study

Journal of Radiotherapy in Practice ◽

10.1017/s146039692000117x ◽

2021 ◽

pp. 1-6

Author(s):

Kenichi Matsumoto ◽

Akihiko Miyamoto ◽

Tomoya Kawase ◽

Taro Murai ◽

Yuta Shibamoto

Keyword(s):

Pancreatic Cancer ◽

Locally Advanced ◽

Intensity Modulated Radiotherapy ◽

Dose Intensity ◽

Progression Free Survival ◽

Concurrent Chemotherapy ◽

Metastatic Pancreatic Cancer ◽

High Dose ◽

Chemotherapy Group ◽

Intensity Modulated

Abstract Aim: To evaluate the efficacy of concurrent chemotherapy and high-dose (≥55 Gy) intensity-modulated radiotherapy (CCIMRT) in comparison with chemotherapy alone and intensity-modulated radiotherapy (IMRT) alone for unresectable locally advanced or metastatic pancreatic cancer. Methods: Forty-six patients with pancreatic cancer undergoing CCIMRT (n = 17), chemotherapy alone (n = 16) or IMRT alone (n = 13) were analysed. Overall survival (OS), locoregional progression-free survival (LRPFS) and gastrointestinal toxicities were evaluated. The median radiation dose was 60 Gy (range, 55–60) delivered in a median of 25 fractions (range, 24–30). Gemcitabine (GEM) alone, GEM + S-1, S-1 alone, FOLFIRINOX and GEM + nab-paclitaxel were used in CCIMRT and chemo-monotherapy. Results: The 1-year OS rate was 69% in the CCIMRT group, 27% in the chemotherapy group and 38% in the IMRT group (p = 0·12). The 1-year LRPFS rate was 73, 0 and 40% in the 3 groups, respectively (p = 0·012). Acute Grade ≥ 2 gastrointestinal toxicity (nausea, diarrhea) was observed in 12% (2/17) in the CCIMRT group, 25% (4/16) in the chemotherapy group and 7·7% (1/13) in the IMRT group (p = 0·38). Late Grade 3 gastrointestinal bleeding was observed in 6·3% (1/16) in the chemotherapy group. Conclusion: High-dose CCIMRT yielded acceptable toxicity and favorable OS and LRPFS.

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