Greater than 3-year follow-up of concomitant gemcitabine, capecitabine, and radiation therapy in locally advanced or incompletely resected pancreatic cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14708-e14708
Author(s):  
William H. Sherman ◽  
Kyung Chu ◽  
John Allendorf ◽  
John A Chabot ◽  
Beth Schrope ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Median Survival ◽  
Residual Disease ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Positive Margin ◽  
Pancreatic Cancer Cells ◽  
Conformal Fields ◽  
One Year

e14708 Background: When either gemcitabine (G) or capecitabine (X) are combined with RT, the median survival is less than 12 months. Approximately 30% of patients progress during the 9 week period of treatment and re-assessment. The benefit of RT in the post-op setting has been questioned. Co-administration of G and X is synergistic against pancreatic cancer cells and both are radiation sensitizers. They were combined with RT. Methods: A retrospective analysis was done on 48 patients treated with GTX (G, docetaxel (T) and X) followed by radiation therapy with concomitant G and X. RT was delivered by conformal fields or IMRT in 180 cGy fractions to 5040 cGy. X, 1,000 mg/m2 was given days 1 to 10 and days 16 to 25 of RT and G, 750 mg/m2 over 90 minutes, was given on days 5, 10, 20 and 25 of RT. The end-points were toxicity and local disease control. Results: 14 patients with positive margin of resection were treated adjuvantly and 34 patients with arterial involvement were treated neo-adjuvantly. No patient developed evidence of metastasis within the 9 weeks after starting RT. There were no bowel perforations, pancreatitis or delayed strictures. The therapy was well tolerated. Grade 3/4 toxicities were: thrombocytopenia 29%, leucopenia 38%, anemia 43%, enteritis 10% and infection 8%. 2 patients had GI bleeding from telangectasias more than 6 months after completing RT. The group of 14 treated adjuvantly had survival of 100% at 1 year, 86% at 2 years. 7 (57%) are beyond 3 years and have not relapsed. 34 patients treated neo-adjuvantly had one year survival of 85%. Of the 34 patients, 16 (47%) are alive with a median survival of 24 months (95% CI 20.7, 31.7.) 22 had resections with a median OS of 25.7 M (range 8.8 to 74.8 M.) 13 have not relapsed (13.6 to 74.8 M.) On pathology, there were 3 CR’s (14%,) 6 (27%) with scattered microscopic disease and 13 (59%) with macroscopic residual disease. Conclusions: G and X can be combined safely with radiation therapy to achieve local control of pancreatic cancer. Our results suggest that the aforementioned therapy, when combined with surgery, increases the long-term disease-free survival over results reported in the literature.

A phase II study of capecitabine plus concomitant radiation therapy followed by durvalumab (MEDI4736) as preoperative treatment in rectal cancer (PANDORA).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. TPS259-TPS259
Author(s):  
Stefano Tamberi ◽  
Elisa Grassi ◽  
Maria aurelia Barbera ◽  
Jody Corbelli ◽  
Giorgio Papiani ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Radiation Therapy ◽  
Complete Remission ◽  
Phase Ii ◽  
Residual Disease ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Preoperative Treatment ◽  
Multi Centre Study ◽  
Free Survival

TPS259 Background: The standard treatment for cT3-4 N0-1 rectal cancer is preoperative chemo-radiation therapy (CT/RT). The combination of capecitabine plus long course radiotherapy (RT) is standard therapy in this setting. Pathologic Complete remission (pCR) can be considered as surrogate end point of efficacy of treatment in terms of disease free survival (DFS). Clinical complete remission (cCR) is an important endpoint for “wait and see” strategy. In the PACIFIC trial in non-small cell lung cancer the patients were treated with durvalumab maintenance after CT/RT with advantage in progression free survival. Preclinical data points heavily toward a strong synergy between RT and immune treatments. Furthermore, a systemic effect of RT is possible when enhanced by targeted immune treatments. Methods: This is a prospective phase II, open label, single arm, multi-centre study to evaluate the activity of an innovative sequence in operable rectal cancer: standard concomitant CT/RT therapy with 825 mg/m2 twice daily capecitabine every day and 5040 cGy radiotherapy for 5 days per week for 5 weeks followed by 1500 mg Q4W durvalumab for 3 administration. After 9-10 weeks from neoadjuvant therapy will be performed re-staging with CT and MRI scan. Surgery will be performed at week 10-12 from the end of CT/RT. Primary Objective: pCR rate, defined as a TRG 3-4 according to DWORAK criteria. Secondary Objectives: Safety of treatment with durvalumab; cCR rate after durvalumab treatment before surgery and DFS. cCR will be evaluated with clinical, endoscopic and radiological assessment to look for evidence of residual disease. DFS will be evaluated during a follow up of 5 years. Exploratory Objective: Biological translational analysis of tumor biomarkers will be performed on the endoscopy biopsy done at the diagnosis and on the biopsy performed after the CT/RT prior to treatment with durvavalumab. We hypothesize that the addition of durvalumab after standard CT/RT for the treatment of locally advanced rectal cancer may improve the pathological response rate and we have planned to enlist 60 patients in 7 centers with an enrollment period of 12 months, already underway. Clinical trial information: NCT04083365.

Long-term results of concurrent gemcitabine (G) and radiotherapy (GRT) for locally advanced (LA) or high-risk resected (R) pancreatic cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4101-4101
Author(s):  
C. Townsley ◽  
A. M. Brade ◽  
C. Brezden-Masley ◽  
D. Hedley ◽  
S. Gallinger ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
High Risk ◽  
Phase I ◽  
Median Survival ◽  
Locally Advanced ◽  
Positive Margin ◽  
Long Term Results ◽  
Patient Request ◽  
Best Response ◽  
Intent To Treat

4101 Background: G is active against pancreatic carcinoma and is a potent radiosensitizer. We present extended follow up data from a phase I/II study of patients treated with combination GRT. Methods: Eligible patients had either LA or high-risk resected [R] pancreatic cancer [positive nodes or positive margin]. 28 were enrolled in a Phase I study of increasing doses of radiotherapy (35 Gy [n = 7]/43.75 Gy [n = 11]/52.5 Gy [n = 10] given over 4, 5 or 6 weeks, respectively in 1.75 Gy fractions) concurrently with 40 mg/m2 gemcitabine biweekly. Subsequently 35 were treated with induction gemcitabine (G) 1000 mg/m2 7/8 weeks followed by concurrent bi-weekly gemcitabine (40 mg/m2) with 52.5 Gy (30 fractions of 1.75 Gy over 6 weeks). In total there were 63 patients (31 LA and 32 R) treated between March 1999–July 2001. Results: In the LA population the best response observed was CR - 1, PR - 2, SD - 10, PD - 10. GRT was not delivered to 8 patients due to progression on G alone (n = 5) or patient request (n = 3). By intent to treat analysis, the median survival in LA disease was 15.1 months and the 2 year survival was 19%. In the resected population the median time to progression was 14.3 months, the median survival was 17.9 months and the 5 year survival was 19%. The treatment was generally well tolerated during both the induction G and the GRT ( Table ). Conclusion: Survival for both LA and HR patients with this concurrent gemcitabine radiotherapy regimen is promising and warrants further investigation. [Table: see text] No significant financial relationships to disclose.

Molecular Processes Involved in Pancreatic Cancer and Therapeutics

2020 ◽  
Vol 14 ◽  
Author(s):  
Subhajit Makar ◽  
Abhrajyoti Ghosh ◽  
Divya ◽  
Shalini Shivhare ◽  
Ashok Kumar ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Molecular Mechanisms ◽  
Early Stage ◽  
Locally Advanced ◽  
Therapeutic Strategies ◽  
Screening Methods ◽  
Pancreatic Cancer Cells ◽  
Systemic Treatments ◽  
Cancer Initiation ◽  
Novel Therapeutic Strategies

: Despite advances in the development of cytotoxic and targeted therapies, pancreatic adenocarcinoma (PAC) remains a significant cause of cancer mortality worldwide. It is also difficult to detect it at an early stage due to numbers of factors. Most of the patients are present with locally advanced or metastatic disease, which precludes curative resection. In the absence of effective screening methods, considerable efforts have been made to identify better systemic treatments during the past decade. This review describes the recent advances in molecular mechanisms involved in pancreatic cancer initiation, progression, and metastasis. Additionally, the importance of deregulated cellular signalling pathways and various cellular proteins as potential targets for developing novel therapeutic strategies against incurable forms of pancreatic cancer is reported. The emphasis is on the critical functions associated with growth factors and their receptors viz. c-MET/HGF, CTHRC1, TGF-β, JAK-STAT, cyclooxygenase pathway, WNT, CCK, MAPK-RAS-RAF, PI3K-AKT, Notch, src, IGF-1R, CDK2NA and chromatin regulation for the sustained growth, survival, and metastasis of pancreatic cancer cells. It also includes various therapeutic strategies viz. immunotherapy, surgical therapy, radiation therapy and chemotherapy.

scholarly journals Development of an Objective Scoring System for Endoscopic Assessment of Radiation-Induced Upper Gastrointestinal Toxicity

Cancers ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 2136
Author(s):  
Daniel Lin ◽  
Shalini Moningi ◽  
Joseph Abi Jaoude ◽  
Ben S. Singh ◽  
Irina M. Cazacu ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Scoring System ◽  
Interobserver Agreement ◽  
Locally Advanced ◽  
Severe Toxicity ◽  
Cancer Trial ◽  
Gi Toxicity ◽  
Upper Gastrointestinal ◽  
Toxicity Scoring

We developed and implemented an objective toxicity scoring system to be used during endoscopic evaluation of the upper gastrointestinal (GI) tract in order to directly assess changes in toxicity during the radiation treatment of pancreatic cancer. We assessed and validated the upper GI toxicity of 19 locally advanced pancreatic cancer trial patients undergoing stereotactic body radiation therapy (SBRT). Wilcoxon-signed rank tests were used to compare pre- and post-SBRT scores. Comparison of the toxicity scores measured before and after SBRT revealed a mild increase in toxicity in the stomach and duodenum (p < 0.005), with no cases of severe toxicity observed. Kappa and AC1 statistics analysis were used to evaluate interobserver agreement. Our toxicity scoring system was reliable in determining GI toxicity with a good overall interobserver agreement for pre-treatment scores (stomach, κ = 0.71, p < 0.005; duodenum, κ = 0.88, p < 0.005) and post-treatment scores (stomach, κ = 0.71, p < 0.005; duodenum, κ = 0.76, p < 0.005). The AC1 statistics yielded similar results. With future usage, we hope this scoring system will be a useful tool for objectively and reliably assessing changes in GI toxicity during the treatment of pancreatic cancer and for GI toxicity assessments and comparisons during radiation therapy research trials.

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