Effect of nutritional status and support on survival in esophageal cancer patients undergoing combined modality therapy

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20641-e20641
Author(s):  
J. P. Plastaras ◽  
J. C. Haynes ◽  
R. Mick ◽  
L. M. Hertan ◽  
A. I. Urdaneta ◽  
...  
Keyword(s):  
Weight Loss ◽  
Esophageal Cancer ◽  
Nutritional Status ◽  
Cox Regression ◽  
Combined Modality Therapy ◽  
Locally Advanced ◽  
Nutritional Supplements ◽  
Curative Intent ◽  
Cox Regression Analysis ◽  
The Impact

e20641 Background: Baseline nutritional status is associated with clinical outcomes in esophageal cancer. Moreover, nutritional support during chemoradiation has been shown to improve outcomes in other disease sites. This retrospective study evaluated the impact of nutritional interventions and baseline nutritional status on outcomes in patients (pts) with locally advanced esophageal cancer. Methods: A retrospective review was performed of 132 pts treated with curative intent using radiation (RT) between 1986 and 2007 at the Hospital of the University of Pennsylvania. The median age of the population was 60 years (range: 33–86). Esophagectomy was performed in 70%, with adjuvant RT in 60% and neoadjuvant RT in 40%. Concurrent chemotherapy was given to 85% of the group. Nutritional counseling was provided to 83% of pts. During RT, oral or enteral nutritional supplements were provided to 77% of pts and intravenous fluids (IVF) were given to 38%. Median follow-up was 14.1 months. Results: Median survival from end of radiation was 1.5 yrs. Median absolute and percentage weight loss during RT were 6.2 lbs and 3.8%, respectively. Median percentage decrease in hemoglobin and albumin were 5.7% and 9.1%, respectively. Univariable Cox regression analysis demonstrated a statistically significant association between weight loss of ≥5 lbs during RT and worse survival (HR 1.74, 95% CI 1.09 - 2.79, p=0.02). Decrease in hemoglobin of 5% or more (HR 1.22, 95% CI 0.59 - 2.54) and decrease in albumin of 10% or more (HR 1.09, 95% CI 0.48 - 2.48) were not associated with survival. Patients who received only nutritional supplements during RT survived significantly longer (p=0.03) than pts who received IVF regardless of nutritional supplementation (HR 2.12, 95% CI 1.12 - 4.01) or pts who received neither nutritional supplements nor IVF (HR 1.8, 95% CI 1.03 - 3.14). Conclusions: Weight loss during RT predicted for worse survival. Nutritional factors before and during RT may be important in outcomes in patients with esophageal cancer and may be modifiable. The use of IVF may be a potential indicator of worse prognosis. Future prospective studies should consider these factors in trial design. No significant financial relationships to disclose.

Survival differences between preoperative and postoperative radiation in esophageal cancer treated with combined modality therapy: A SEER analysis.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 78-78
Author(s):  
Andrzej Pawel Wojcieszynski ◽  
Abigail Berman Milby ◽  
John Peter Plastaras ◽  
James M. Metz ◽  
Smith Apisarnthanarax
Keyword(s):  
Esophageal Cancer ◽  
Cox Regression ◽  
Combined Modality Therapy ◽  
Univariate Analysis ◽  
Locally Advanced ◽  
Survival Outcomes ◽  
Advanced Esophageal Cancer ◽  
Carcinoma Of The Esophagus ◽  
Survival Differences ◽  
Locally Advanced Esophageal Cancer

78 Background: The effect of radiation therapy (RT) sequencing with surgery on clinical outcomes for locally advanced esophageal cancer patients is unclear. We hypothesized that RT given prior to surgery has superior survival outcomes compared to RT delivered after surgery. Methods: Patients with the following inclusion criteria were identified within 17 Surveillance, Epidemiology, and End Results (SEER) registries from 1988-2006: adenocarcinoma or squamous cell carcinoma of the esophagus, esophagectomy, and RT. Data on demographics, tumor characteristics, and survival outcomes were extracted and compared between patients receiving preoperative and those receiving postoperative RT. Cox regression univariate and multivariate analyses were performed to identify parameters that were associated with cause-specific (CSS) and overall survival (OS). Results: A total of 2,579 patients met the defined criteria. Of these patients, 1,689 received preop RT and 890 received postop RT. Patients receiving preop RT compared to postop RT had improved 5-yr CSS (41% vs. 31%, p<0.0001) and OS (33% vs. 23%, p<0.0001). On univariate analysis, RT sequence, histology, T stage, nodal status, number lymph nodes examined, age, gender, marital status, race, and county income were significant independent predictors of OS. On multivariate analysis ( table ), preop RT continued to remain statistically significant for OS (HR 0.88; p = 0.034). Conclusions: Preoperative RT is associated with superior overall and cause-specific survival compared to postoperative RT and should be the preferred approach in combination with surgery for locally advanced esophageal cancer. [Table: see text]

Can induction chemotherapy improve dysphagia in locally advanced esophageal/GEJ cancer?

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 148-148
Author(s):  
Elizabeth Won ◽  
David H. Ilson ◽  
Jessica Herrera ◽  
Yelena Yuriy Janjigian ◽  
Geoffrey Yuyat Ku ◽  
...  
Keyword(s):  
Weight Loss ◽  
Esophageal Cancer ◽  
Nutritional Status ◽  
Induction Chemotherapy ◽  
Locally Advanced ◽  
Concurrent Chemoradiation ◽  
Tube Placement ◽  
Average Weight ◽  
Feeding Tubes ◽  
Presenting Symptoms

148 Background: Dysphagia is one of the most common presenting symptoms in esophageal cancer (EC) and can lead to significant nutritional decline, which is associated with increased toxicity and poor outcomes. Invasive feeding tubes or endoscopic stents are frequently used to improve nutrition in this setting. We evaluated the role of induction chemotherapy prior to concurrent chemoradiation as presurgical treatment in improving dysphagia. Methods: Retrospective analysis of 4 prospective studies conducted at MSKCC with induction chemotherapy followed by concurrent chemoradiation and surgery in locally advanced esophageal/GEJ cancer. Regimens included cisplatin/paclitaxel, cisplatin/irinotecan, and cisplatin/irinotecan/bevacizumab. Dysphagia was graded prospectively using a validated dysphagia scale. Response of dysphagia and nutritional status to induction chemotherapy was evaluated. Results: Of 161 patients (pts) undergoing induction chemotherapy, [median age 59(21-76), KPS 90 (70-100), 77% adenocarcinoma], 121 (76%) had dysphagia, with 59(37%) having grade 2 dysphagia or higher (20% Stage II, 80% Stage III). 6(4%) required EGD dilatation/stent and none required feeding tube placement prior to treatment. 22% patients had>10% body weight loss prior to treatment and average weight loss in all pts was 4.3kg. After induction chemotherapy, 104 (64%) had improvement in dysphagia. This was associated with a weight gain in 42% of pts. Only 7(4%) had worsening dysphagia after induction chemotherapy: 4/7 required feeding tubes (2% of all pts), 2/7 underwent endoscopic dilatation or stent (1% of all pts). 6/7 of these pts with worsening dysphagia had poor short term outcomes after induction treatment: 2/7 progressive disease, 3/7 unresectable at surgery, 1/7 post-operative death. Conclusions: Induction chemotherapy prior to concurrent chemoradiation for locally advanced esophageal cancer can effectively improve swallowing and nutritional status, while mitigating need for feeding tubes or stents in patients with significant dysphagia. Post-induction dysphagia may be prognostic and merits further investigation.

scholarly journals Effect of extending the original eligibility criteria for the “CROSS” neoadjuvant chemoradiotherapy on toxicity and survival in esophageal cancer.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 187-187
Author(s):  
Jan-Binne Hulshoff ◽  
Ellen C. de Heer ◽  
Daphne H. Klerk ◽  
Derk Jan De Groot ◽  
John Theodorus Plukker ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Cox Regression ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Postoperative Mortality ◽  
Hematologic Toxicity ◽  
Eligibility Criteria ◽  
Cox Regression Analysis ◽  
Group I ◽  
The Cross

187 Background: Patients with curable esophageal cancer (EC) which proceed beyond the original CROSS eligibility criteria are also treated with neoadjuvant chemoradiotherapy (nCRT). This study assessed the effect of extending the CROSS eligibility criteria for nCRT on treatment related toxicity and overall survival (OS) in EC. Methods: Included were 161 patients with locally advanced EC (T1N1-3/T2-4aN0-3/M0), treated with the CROSS schedule followed by esophagectomy. Group 1 (N = 90) consisted of patients which met the CROSS criteria and patients in group 2 (N = 71) met the extended eligibility criteria, i.e. including a tumor length of > 8 cm (N = 23), > 10% weight loss (N = 35), > 2 – 4 cm extension in the stomach (N = 21), celiac lymph node metastasis (N = 13), and/or age > 75 years (N = 2). We assessed the differences in hematologic toxicity (≥ grade 3) and 90-day postoperative mortality. Moreover, we assessed the prognostic value on OS with multivariate Cox regression analysis. Results: No difference was found in hematologic toxicity and 90-day mortality. The OS differed significantly (P = 0.003), with a median of 37.3 (95% CI 10.56 – 64.0) and 17.2 (95% CI 13.8 – 20.6) months in group I and II, respectively. Pathological N-stage (P = 0.024), ypT-stage (P = 0.044), and group II (P = 0.006) were independent prognostic factors for OS. Conclusions: Extension of the CROSS study eligibility criteria for nCRT did not affect hematologic toxicity and postoperative mortality, but was prognostic for OS.

scholarly journals Impact of Clinical Markers of Nutritional Status and Feeding Jejunostomy Use on Outcomes in Esophageal Cancer Patients Undergoing Neoadjuvant Chemoradiotherapy

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 3177
Author(s):  
Rishi Jain ◽  
Talha Shaikh ◽  
Jia-Llon Yee ◽  
Cherry Au ◽  
Crystal S. Denlinger ◽  
...  
Keyword(s):  
Weight Loss ◽  
Esophageal Cancer ◽  
Nutritional Status ◽  
Neoadjuvant Chemoradiotherapy ◽  
Hematologic Toxicity ◽  
Clinical Markers ◽  
Jejunostomy Tube ◽  
Feeding Jejunostomy ◽  
Reduce Weight Loss ◽  
The Impact

Background: Patients with esophageal cancer (EC) have high rates of malnutrition due to tumor location and treatment-related toxicity. Various strategies are used to improve nutritional status in patients with EC including oral and enteral support. Methods: We conducted a retrospective analysis to determine the impact of malnutrition and prophylactic feeding jejunostomy tube (FJT) placement on toxicity and outcomes in patients with localized EC who were treated with neoadjuvant chemoradiation therapy (nCRT) followed by esophagectomy. Results: We identified 125 patients who were treated with nCRT between 2002 and 2014. Weight loss and hypoalbuminemia occurred frequently during nCRT and were associated with multiple adverse toxicity outcomes including hematologic toxicity, nonhematologic toxicity, grade ≥3 toxicity, and hospitalizations. After adjusting for relevant covariates including the specific nCRT chemotherapy regimen received and the onset of toxicity, there were no significant associations between hypoalbuminemia, weight loss, or FJT placement and relapse-free survival (RFS) or overall survival (OS). FJT placement was associated with less weight loss during nCRT (p = 0.003) but was not associated with reduced toxicity or improved survival. Conclusions: Weight and albumin loss during nCRT for EC are important factors relating to treatment toxicity but not RFS or OS. While pretreatment FJT placement may reduce weight loss, it may not impact treatment tolerance or survival.

Impact of CDKN2A/b status in pancreatic cancer (PC).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 759-759
Author(s):  
Kaitlin Annunzio ◽  
Claire Griffiths ◽  
Igli Arapi ◽  
Matthew Lasowski ◽  
Arun K. Singavi ◽  
...  
Keyword(s):  
Cox Regression ◽  
Clinical Stage ◽  
Locally Advanced ◽  
Predictive Biomarkers ◽  
Marginal Effect ◽  
Prognostic Impact ◽  
Borderline Resectable ◽  
Curative Intent ◽  
Cox Regression Analysis ◽  
Response To Chemotherapy

759 Background: PC is a lethal disease with limited treatment options. We utilized Comprehensive Genomic Profiling (CGP) to identify putative prognostic and/or predictive biomarkers. Methods: We retrospectively reviewed PC patients (pts) at our institution who underwent CGP utilizing the Foundation One assay. CGP was performed on hybrid-capture, adaptor ligation-based libraries for up to 315 genes plus 47 introns from 19 genes frequently rearranged in cancer. PC pts were categorized by clinical stage – localized (resectable and borderline resectable PC; LPC), locally advanced (LAPC) and metastatic (mPC). Effect of gene alterations (GAs) with at least 10% prevalence were analyzed. The marginal effect of each gene on radiographic response and survival outcomes was estimated using proportional odds and multivariate Cox regression analysis, respectively, adjusting for stage. Results: Ninety-three pts were identified - median age was 63, 55% were male, and 50% were smokers. Clinical stage at diagnosis was LPC, LAPC and mPC in 42 (45%), 23 (25%) and 28 (30%) pts, respectively. The most commonly altered genes were KRAS (94%), TP53 (75%), CDKN2A (41.2%) and SMAD4 (32.9%). All patients were microsatellite stable and the median tumor mutational burden was 1.7. 5-FU (52%) or Gemcitabine (46%) based chemotherapy combinations were utilized as the first systemic therapy. Median overall survival for patients with LPC, LAPC and mPC were 30.7, 28.8 and 9.6 months respectively. Thirty-eight (91%) pts with LPC underwent curative intent surgery compared to 15 (65%) pts with LAPC (p = 0.019). Thirty-five (95%) pts with wild type (WT) CDKN2A and 47 (94%) pts with WT CDKN2B underwent curative intent surgery compared to 13 (65%) and 1(14%) pt(s) with GAs in CDKN2A and CDKN2B respectively (p = 0.003 and p < 0.0001 respectively). The response to chemotherapy was statistically significantly higher in pts with WT CDKN2A (53%) and CDKN2B (48%) compared to pts with GAs in CDKN2A (19%) and CDKN2B (12%) (p = 0.03 and p = 0.05, respectively). Conclusions: GAs in CDKN2A/B may have a predictive and possibly a prognostic impact. The clinical validity and biological relevance of these findings need to be further explored in larger studies.

The impact of lung and bone metastases on prognosis in advanced PDAC.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 494-494
Author(s):  
Grainne M. O'Kane ◽  
Adriana Fraser ◽  
Stephanie Moignard ◽  
Anna Dodd ◽  
Sean Creighton ◽  
...  
Keyword(s):  
Bone Metastases ◽  
Metastatic Disease ◽  
Cox Regression ◽  
Locally Advanced ◽  
Multivariable Analysis ◽  
Ductal Adenocarcinoma ◽  
Peritoneal Disease ◽  
Cox Regression Analysis ◽  
Cytotoxic Treatment ◽  
The Impact

494 Background: Pancreatic ductal adenocarcinoma (PDAC) remains a highly fatal disease inherently resistant to cytotoxic treatment. Despite the prevalence of liver and peritoneal metastases, subsets of patients also develop lung and bone metastases highlighting phenotypic heterogeneity. We reviewed the prognostic implications of metastatic sites on survival. Methods: This retrospective cohort study included all patients with PDAC who received surgical or oncological treatment at the University Health Network from September 2012 until December 2016. Clinical and pathological variables were obtained from patient electronic records. Radiological images and pathology reports were reviewed to ascertain sites of metastatic disease. The Kaplan-Meier method for survival and multivariable cox regression analysis identified prognostic factors. Results: 1153 patients were reviewed and 985 were included. 55% were male and the median age at diagnosis was 67 years. 287 (29%) completed curative surgery and 698 (71%) had locally advanced or metastatic disease; the median survival was 22 months and 9 months respectively. Lung and bone metastases were present in 18% (N = 180) and 6% (N = 58) of patients. In multivariable analysis increasing age and stage at diagnosis correlated with inferior survival (p < 0.0001) and the presence of any lung (HR 0.77; 95% CI 0.63-0.94, p = 0.01) or bone metastases (HR 0.74; 95% CI 0.54-1.0, p = 0.05) resulted in improved outcomes. Liver and peritoneal disease were not prognostic. Sex and family history of PDAC did not associate with survival. There was no association between site of metastases and sex however patients with bone metastases were significantly younger at first diagnosis (median age 63yrs, p < 0.01). Conclusions: Patients with advanced PDAC and metastases to lung or bone may represent distinct biological subtypes of PDAC. Molecular profiling of available tissue is ongoing.

The value of lymphadenectomy in esophageal cancer after neoadjuvant chemoradiation.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 79-79
Author(s):  
Basem Azab ◽  
Francisco Igor Macedo ◽  
Omar Picado ◽  
Caroline Ripat ◽  
Dido Franceschi ◽  
...  
Keyword(s):  
Cox Regression ◽  
Locally Advanced ◽  
Postoperative Mortality ◽  
Complete Response ◽  
Neoadjuvant Chemoradiation ◽  
National Cancer Data Base ◽  
Cox Regression Analysis ◽  
Cancer Data ◽  
The Impact ◽  
Total Lymph Node

79 Background: There are conflicting reports on the value of the extent of post neoadjuvant chemoradiation (NCRT) lymphadenectomy (LND) in locally advanced esophageal adenocarcinoma (E-ADC) and squamous cell carcinoma (E-SCC). We sought to study the impact of LND variables [positive and total lymph node (LN) number and LN ratio (LNR)] on oncological outcomes in these patients. Methods: The National Cancer Data Base 2004-2014 was queried for patients with NCRT followed by esophagectomy. The median examined LN number was used to divide the patients into a higher (> 12) and lower (≤ 12) LND groups. The primary outcome was overall survival (OS) and secondary outcomes were 30- and 90-day postoperative mortality. Results: A total 4708 patients were included. The median of positive, negative LN, and LNR were and (0, 11, 0%). The median and 5-year OS for higher LND group were higher than the lower LND group (39 vs. 32 months, 38% vs. 34%), p < 0.0001. OS was not significantly different among E-SCC subset or among those who achieved pathological complete response (pCR). The higher LND group had better 30- and 90-day postoperative mortality rates (61/2335 = 2.6%, 141/2308 = 6.1%) than lower LND group (86/2262 = 3.8%, 184/2251 = 8.2%), p = 0.01 and 0.001, respectively . In multivariate Cox regression analysis, higher LND group (HR 0.88, 95% CI 0.81-0.96, p = 0.004) and LNR (per 10% increase: 1.11, 95% CI 1.09-1.13, p < 0.0001) were significant predictor of OS. Conclusions: The LND (> 12 examined LN) remains as a crucial treatment goal after NCRT with potential survival benefit, especially among E-ADC and those did not achieve pCR.

The impact of previous tracheostomy in patients with locally advanced squamous cell carcinoma of the larynx submitted to concurrent chemotherapy and radiation

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6004-6004
Author(s):  
F. L. Dias ◽  
D. Herchenhorn ◽  
I. A. Small ◽  
C. M. Araújo ◽  
C. G. Ferreira ◽  
...  
Keyword(s):  
Prognostic Factor ◽  
Treatment Response ◽  
Cox Regression ◽  
Performance Status ◽  
Locally Advanced ◽  
Treatment Strategies ◽  
Concurrent Chemotherapy ◽  
Cancer Specific Survival ◽  
Cox Regression Analysis ◽  
The Impact

6004 Background: The combination of chemotherapy and radiotherapy is a standard treatment for locally advanced larynx cancer. Patients presenting with previous tracheostomy due to aiway obstruction have a worse clinical outcome when submitted to a total laryngectomy or radiotherapy; the impact of previous tracheostomy is not clear in patients submitted to chemotherapy combined with radiation. Methods: A single-institutional study, patients with stage III and IV laryngeal carcinoma were prospectively selected from 2000 to 2003. Treatment consisted of Cisplatin 100 mg/m2 every three weeks for 3 cycles concurrent with radiotherapy to a total dose of 70.2 Gy. Prognostic factors like stage, age, performance status, chemotherapy completion, treatment response and previous tracheostomy were correlated on univariate and multivariate analysis with treatment response, progression-free and overall survival. Results: Forty-nine patients were selected, previous tracheostomy was performed in 12 (24,5%) before chemo/radiation therapy. Patients with tracheostomy had an inferior median overall cancer-specific survival (12 months versus 56 months), HR 2.37 (CI 95% 1.43–3.93) p=0.001, progression free-survival HR 2.8 (CI 95% 1.61–4.89) p<0.001 and lower rates of complete responses (40 versus 75%). The impact of previous tracheostomy was not altered when adjusted by number of chemotherapy cycles, tumor stage, performance status, age or treatment response. On a cox regression analysis for overall cancer-specific survival it was the strongest prognostic factor HR 7.75 (CI 95% 2.75–21.84) p<0.001. Conclusions: Previous tracheostomy is an independent negative prognostic factor for patients submitted to chemotherapy combined with radiation. Tracheostomty should be considered in the design of future studies and to select patients to different treatment strategies. No significant financial relationships to disclose.

Impact of comorbidity in the choice of curative treatment for esophageal cancer: A population-based study.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 131-131 ◽  
Author(s):  
Zohra Faiz ◽  
Margreet Van Putten ◽  
Rob H.A. Verhoeven ◽  
Johanna W. van Sandick ◽  
Grard A. P. Nieuwenhuijzen ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Treatment Decision ◽  
Population Based ◽  
Curative Intent ◽  
Kaplan Meier ◽  
Co Morbidity ◽  
Study Support ◽  
The Impact

131 Background: Surgery after neoadjuvant chemoradiotherapy (nCRT) is the most common treatment with curative intent for esophageal cancer (EC) patients. Definitive chemoradiotherapy (dCRT) is an alternative for patients who are not eligible for resection because of comorbidity. The purpose of this retrospective study was to evaluate patient and tumor characteristics which are associated with the type of treatment. Methods: We selected all consecutive patients with a locally advanced EC (cT1 N + / T2-3N0-3M0-1a) who were treated with curative intent (nCRT, dCRT or surgery only) in the South East Netherlands between 1995 and 2013. For a proper assessment of the impact of co-morbidity, T4 tumors were excluded. The effect of co-morbidity on treatment decision and on survival was analyzed using a multivariable logistic regression and Kaplan-Meier method. Survival time was defined as time from 6 months after diagnosis until death or until January 1st 2015 for patients who were still alive. Results: Of the 1098 patients, surgery only was performed in 46%, nCRT in 28% and dCRT in 26%. Patients with ≥ 2 co-morbidities underwent more frequently dCRT (OR = 2.35; 95% CI: 1.45-3.86), or resection only (OR = 2.29; 95% CI: 1.41-3.69). Patients > 75 years (OR = 6.66; 95% CI: 3.48-12.77), patients with hypertension and diabetes (OR: 4.05;95% CI: 1.96-8.37-3.90) and patients with cardiovascular (mostly myocardial infarction) and pulmonary comorbidity (OR = 3:33; 95% CI: 1:51 to 7:34) underwent frequently more dCRT than nCRT. Patients with esophageal squamous cell carcinoma (ESCC) also had more frequently dCRT (OR = 2.27; 95% Cl: 1.38-3.73). Patients with an adenocarcinoma and ≥ 2 co-morbidities had favorable 3-year overall survival (OS) after nCRT compared with dCRT and surgery alone (p < 0.01). However, the 3-year OS after nCRT was similar after dCRT in ESCC patients with ≥ 2 co-morbidities (p = 0.75). Conclusions: The results of this study support the treatment with dCRT in patients with SCC of the esophagus, and with at least two co-morbidities, in particular, the combination of cardiovascular / pulmonary disorders and hypertension plus diabetes.

Effect of inflammatory and nutritional (IN) status on induction chemotherapy (CT) followed by chemoradiotherapy (CRT) for locally advanced pancreatic cancer (LAPC): An exploratory subgroup analysis of JCOG1106.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4123-4123
Author(s):  
Nobumasa Mizuno ◽  
Akira Fukutomi ◽  
Junki Mizusawa ◽  
Hiroshi Katayama ◽  
Satoaki Nakamura ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Cox Regression ◽  
Prognostic Score ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Glasgow Prognostic Score ◽  
P Value ◽  
Treatment Benefit ◽  
Cox Regression Analysis ◽  
The Impact

4123 Background: JCOG1106 is a randomized selection phase 2 trial to evaluate the efficacy and safety of CRT (S-1 concurrent RT) with (Arm B) or without (Arm A) induction CT of gemcitabine (GEM) for LAPC. In the final analysis, we selected Arm A as a promising regimen due to a poorer 2-year overall survival (OS) of Arm B, in spite of a favorable 1-year OS with crossing of the survival curves around 1-year (Ioka, ESMO2016). Therefore, this study aimed to explore subgroups benefit more from either treatment. IN statuses defined by such as serum C-reactive protein (CRP) and serum albumin (Alb) are recognized as prognostic and predictive factors in patients (pts) with various cancers receiving CT or CRT. We hypothesized that IN status may modify the effect of induction CT. Methods: Subjects were all eligible pts who were enrolled in JCOG1106 (n = 51/49 in Arm A/B). Glasgow Prognostic Score (GPS) was classified by baseline CRP and Alb. Pts with a CRP ≤ 10 mg/L and Alb ≥ 35 g/L were allocated to GPS 0, with a CRP > 10 mg/L or Alb < 35 g/L to GPS 1, and with a CRP > 10 mg/L and Alb < 35 g/L to GPS 2. This exploratory subgroup analysis was performed by Cox regression analysis to investigate the impact of IN status at baseline on OS. Less than 0.1 of P-value for interaction was regarded as significant. Results: GPS, CRP and Alb showed significant treatment interactions in terms of OS. HRs of Arm B to Arm A were 1.35 (0.82–2.23) and 0.59 (0.24–1.50) in the GPS 0 (n = 44/34 in Arm A/B) and GPS 1/2 group (n = 7/15) ( P-interaction = 0.06). HRs were 2.57 (1.36–4.86) and 0.70 (0.37–1.32) in the low CRP group (≤ 1.35 mg/L, n = 25/25) and high CRP ( > 1.35 mg/L, n = 26/24) ( P= 0.01). HRs were 1.62 (0.77–3.40), 2.70 (1.17–6.23) and 0.52 (0.24–1.13) in the 1st (≤ 0.7 mg/L, n = 16/16), 2nd ( > 0.7, ≤ 3.0 mg/L, n = 20/16), and 3rd tertiary CRP group ( > 3.0 mg/L, n = 15/17) ( P= 0.01). HRs were 2.29 (1.11–4.69) and 0.89 (0.51–1.54) in the high Alb group ( > 40 g/L, n = 23/17) and low Alb (≤ 40 g/L, n = 28/32) ( P= 0.04). Arm B showed better survival in subgroups of GPS 1/2, higher CRP or lower Alb compared to Arm A. Conclusions: Pts with poor IN status may have treatment benefit of induction CT followed by CRT for LAPC. Clinical trial information: UMIN000006811.

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