Metabolic Imaging Predicts Response, Survival, and Recurrence in Adenocarcinomas of the Esophagogastric Junction

2006 ◽  
Vol 24 (29) ◽  
pp. 4692-4698 ◽  
Author(s):  
Katja Ott ◽  
Wolfgang A. Weber ◽  
Florian Lordick ◽  
Karen Becker ◽  
Raymonde Busch ◽  
...  
Keyword(s):  
Survival Rate ◽  
Metabolic Activity ◽  
Esophagogastric Junction ◽  
Response Rate ◽  
Metabolic Response ◽  
Locally Advanced ◽  
Metabolic Imaging ◽  
Preoperative Treatment ◽  
Histopathologic Response ◽  
Tumor Stages

PurposeA previous study suggested that measurement of therapy-induced changes in tumor glucose metabolism by positron emission tomography (PET) with the glucose analog [18F]fluorodeoxyglucose (FDG) allows to select patients most likely to benefit from preoperative chemotherapy in adenocarcinomas of the esophagogastric junction (AEG). The aim of this study was to prospectively validate these findings by using an a priori definition of metabolic response.Patients and MethodsSixty-five patients with locally advanced AEGs were included. Tumor glucose utilization was quantitatively assessed by FDG-PET before chemotherapy and 14 days after initiation of therapy. Patients were classified as metabolic responders when the metabolic activity of the primary tumor had decreased by more than 35% at the time of the second PET.ResultsMetabolic responders showed a high histopathologic response rate (44%) with a 3-year survival rate of 70%. In contrast, prognosis was poor for metabolic nonresponders with a histopathologic response rate of 5% (P = .001) and a 3-year survival rate of 35% (P = .01). A multivariate analysis (covariates: ypT-, ypN-category, histopathologic response) demonstrated that metabolic response was the only factor predicting recurrence (P = .018) in the subgroup of completely resected (R0) patients.ConclusionThis study prospectively demonstrates that changes in tumor metabolic activity during chemotherapy predict response, prognosis, and recurrence. These data provide the basis for clinical trials in which preoperative treatment is changed for patients without a metabolic response early in the course of therapy. PET-guided induction therapy may even be applicable to earlier tumor stages because surgery is only minimally delayed in nonresponding patients.

Prediction of Response to Preoperative Chemotherapy in Adenocarcinomas of the Esophagogastric Junction by Metabolic Imaging

2001 ◽  
Vol 19 (12) ◽  
pp. 3058-3065 ◽  
Author(s):  
Wolfgang A. Weber ◽  
Katja Ott ◽  
Karen Becker ◽  
Hans-Joachim Dittler ◽  
Hermann Helmberger ◽  
...  
Keyword(s):  
Clinical Response ◽  
Preoperative Chemotherapy ◽  
Esophagogastric Junction ◽  
Metabolic Response ◽  
Tumor Regression ◽  
Locally Advanced ◽  
Metabolic Imaging ◽  
Cutoff Value ◽  
Fdg Uptake ◽  
Days Of Therapy

PURPOSE: Preoperative chemotherapy in patients with gastroesophageal cancer is hampered by the lack of reliable predictors of tumor response. This study evaluates whether positron emission tomography (PET) using fluorine-18 fluorodeoxyglucose (FDG) may predict response early in the course of therapy.PATIENTS AND METHODS: Forty consecutive patients with locally advanced adenocarcinomas of the esophagogastric junction were studied by FDG-PET at baseline and 14 days after initiation of cisplatin-based polychemotherapy. Clinical response (reduction of tumor length and wall thickness by > 50%) was evaluated after 3 months of therapy using endoscopy and standard imaging techniques. Patients with potentially resectable tumors underwent surgery, and tumor regression was assessed histopathologically.RESULTS: The reduction of tumor FDG uptake (mean ± 1 SD) after 14 days of therapy was significantly different between responding (−54% ± 17%) and nonresponding tumors (−15% ± 21%). Optimal differentiation was achieved by a cutoff value of 35% reduction of initial FDG uptake. Applying this cutoff value as a criterion for a metabolic response predicted clinical response with a sensitivity and specificity of 93% (14 of 15 patients) and 95% (21 of 22), respectively. Histopathologically complete or subtotal tumor regression was achieved in 53% (eight of 15) of the patients with a metabolic response but only in 5% (one of 22) of the patients without a metabolic response. Patients without a metabolic response were also characterized by significantly shorter time to progression/recurrence (P = .01) and shorter overall survival (P = .04).CONCLUSION: PET imaging may differentiate responding and nonresponding tumors early in the course of therapy. By avoiding ineffective and potentially harmful treatment, this may markedly facilitate the use of preoperative therapy, especially in patients with potentially resectable tumors.

A study of preoperative FOLFIRINOX in potentially curable pancreatic cancer.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 719-719
Author(s):  
Hamed Javan ◽  
Tamim Niazi ◽  
Tsafrir Vanounou ◽  
Jean-Sebastien Pelletier ◽  
Richard Dalfen ◽  
...  
Keyword(s):  
Response Rate ◽  
Locally Advanced ◽  
Dose Intensity ◽  
Primary Objective ◽  
Pathological Response ◽  
Preoperative Treatment ◽  
Adjuvant Setting ◽  
Resection Rate ◽  
Open Label ◽  
Borderline Resectable

719 Background: Although Folfirinox (FFX) prolonged survival in metastatic and adjuvant setting, the role of preoperative FFX is still controversial. Our aim is to evaluate how surgery after neoadjuvant FFX with or without radiotherapy (RT) affects the clinical outcome in these patients. Methods: This is a single arm, open-label, phase 2 prospective study. Based on resectability criteria (NCCN-V.1.2017), patients prospectively were divided into 3 groups of resectable, borderline resectable (BR), locally advanced (LA). Patients received 6 cycles of preoperative FFX. Patients with adequate response, underwent resection. Continuation of chemotherapy or radiation was given to the patients who were deemed unresectable after 6 cycles. Primary objective is time to progression (TTP), and secondary objectives are safety, R0/R1 resection rate, response rate (RR) and overall survival (OS). Results: 20 consecutive patients with pancreatic adenocarcinoma enrolled. The frequency of each group was 4, 8, 8 patients, respectively. Median age was 64 years old (range, 49-78). 45% of patients had primary tumor in head or uncinate process. 25% of cases presented with normal CA 19-9 value. 85% (17/20) of patients completed the preoperative treatment. Folfirinox was given within median of 11.5 weeks (range, 8-17) and median of 6 cycles (range, 1-7). Median relative dose intensity (RDI) was 85.89%. Grade III-IV (G3+4) adverse event (CTCAE-4.03) observed in 47.4% (9/19). RR (RECIST) was 89% (16/18). Best response was partial response (PR) and stable disease (SD) with 22.2% (4/18) and 66.7% (12/18). Resection rate was 64.3% (9/14, 1 case scheduled for resection). R0 and negative lymph node (LN) achieved in 87.50% (7/8) and 62.50% (5/8) of patients. Complete pathological response (cPR) was seen in one patient 12.5% (1/8) who preoperatively reported as SD. Patients TTP and OS will be reported during the meeting. Conclusions: Preoperative FFX was associated with high clinical and pathological response rate translating in high resection rate in majority of BRPC and LAPC, and appears to be a safe treatment strategy. Patients received higher FFX dose intensity than it was reported in adjuvant setting. However, these results need to be assessed in a randomized trial. Clinical trial information: NCT03167112.

Early predictive value of 18F-FDG-PET assessment in advanced esophagogastric junction and gastric cancer patients treated with cetuximab-containing therapy

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15601-e15601
Author(s):  
F. Di Fabio ◽  
C. Pinto ◽  
F. Rojas Llimpe ◽  
P. Castellucci ◽  
S. Fanti ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Fdg Pet ◽  
Esophagogastric Junction ◽  
Metabolic Response ◽  
Objective Response ◽  
Locally Advanced ◽  
Response Assessment ◽  
Standard Uptake Value ◽  
Phase Ii Studies ◽  
18F Fdg

e15601 Background: 18F-FDG-PET/CT (PET) was reported to predict the pathological response during preoperative chemotherapy in esophagogastric junction (GEJ) or gastric (G) cancer pts. The aim of this study is to evaluate the usefulness of an early change in PET at several time-points in predicting response to cetuximab-containing therapy in pts with advanced GEJ or G cancer. Methods: We evaluated 51 pts with locally advanced/metastatic GEJ or G adenocarcinoma who underwent a first line cetuximab- treatment in two Italian phase II studies. Twenty nine pts (GEJ/G = 5/24; locally advanced/metastatic = 2/27) received cetuximab in combination with cisplatin/docetaxel (DOCETUX study) and 22 pts (GEJ/G = 2/20; locally advanced/metastatic = 3/19) received cetuximab in combination with FOLFIRI (FOLCETUX Study). PET scans were performed at baseline, and in FDG-avid pts, again on day 21 in the DOCETUX study and on day 42 in the FOLCETUX study. Metabolic response was defined as a decrease in maximum standard uptake value (SUV) ≥35% on the basis of our previous study (Di Fabio et al., Gastric Cancer 10:221–227, 2007).Objective response, according to RECIST criteria, was assessed by CT scan at baseline and every 6 weeks. Results: Five pts (10.2%) had FDG non- avid tumor (all pts with signet cell carcinoma). In the 46 FDG-avid tumor pts, the median SUV at baseline was 10.3 (range 5.0 - 36.4). The response rate (RR) was significantly higher in pts with a drop ≥35% in SUV from baseline to day 42: 83% (10/12 pts) in metabolic responders vs. 25% (2/8 pts) in non-metabolic responders (p= 0.019). In contrast, the SUV change at day 21 did not correlate with objective response: RR 57.1% (8/14 pts) in metabolic responders vs. 41.7% (5/12 pts) in non-metabolic responders (p= 0.695). The RR in non-avid tumor pts was 20% (1/5 pts). Conclusions.Our study suggests that in advanced gastric cancer pts with FDG-avid tumor the PET predicts objective response at day 42, but not at day 21. A PET response assessment can provide an opportunity to change the treatment in non-responder pts. Prospective trials defining the role of PET in gastric cancer are warranted. No significant financial relationships to disclose.

Prediction of Response to Preoperative Chemotherapy in Gastric Carcinoma by Metabolic Imaging: Results of a Prospective Trial

2003 ◽  
Vol 21 (24) ◽  
pp. 4604-4610 ◽  
Author(s):  
Katja Ott ◽  
Ulrich Fink ◽  
Karen Becker ◽  
Alexander Stahl ◽  
Hans-Joachim Dittler ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Survival Rate ◽  
Preoperative Chemotherapy ◽  
Pet Imaging ◽  
Fdg Pet ◽  
Patient Survival ◽  
Metabolic Response ◽  
Resected Specimen ◽  
Fdg Uptake ◽  
Histopathologic Response

Purpose: We prospectively evaluated the predictive value of therapy-induced reduction of tumor glucose use for subsequent response and patient survival in patients with gastric cancer treated by preoperative chemotherapy. Patients and Methods: Forty-four consecutive patients with locally advanced gastric carcinomas were studied by positron emission tomography with the glucose analog fluorine-18 fluorodeoxyglucose (FDG-PET) at baseline and 14 days after initiation of cisplatin-based polychemotherapy. On the basis of a previous study, a reduction of tumor FDG uptake by more than 35% was used as a criterion for a metabolic response. The metabolic response in FDG-PET was correlated with histopathologic response after completion of therapy (< 10% viable tumor cells in the resected specimen) and patient survival. Results: Thirty-five (80%) of the 44 tumors were visualized with sufficient contrast for quantitative analysis (two of 19 intestinal and seven of 25 nonintestinal tumors showed only low FDG uptake). In the 35 assessable patients, PET imaging after 14 days of therapy correctly predicted histopathologic response after 3 months of therapy in 10 (77%) of 13 responders and 19 (86%) of 22 nonresponders. Median overall survival for patients with a metabolic response has not been reached (2-year survival rate, 90%); for patients without a metabolic response, median survival was only 18.9 months (2-year survival rate, 25%; P = .002) Conclusion: This study prospectively demonstrates that in patients with gastric cancer, response to preoperative chemotherapy can be predicted by FDG-PET early during the course of therapy. By avoiding the morbidity and costs of ineffective therapy, FDG-PET imaging may markedly facilitate the use of preoperative chemotherapy.

scholarly journals Adjuvant SOX Chemotherapy Versus Concurrent Chemoradiotherapy After D2 Radical Resection of Locally Advanced Esophagogastric Junction (EGJ) Adenocarcinoma: Study Protocol for a Randomized Phase III Trial (ARTEG)

2020 ◽  
Author(s):  
Jinwen Shen ◽  
Xiu Zhu ◽  
Yian Du ◽  
Yuan Zhu ◽  
Pengfei Yu ◽  
...  
Keyword(s):  
Survival Rate ◽  
Adjuvant Radiotherapy ◽  
Locoregional Recurrence ◽  
Esophagogastric Junction ◽  
Locally Advanced ◽  
Radical Resection ◽  
Phase Iii ◽  
Control Group ◽  
Free Survival ◽  
Experimental Group

Abstract Background: Survival benefit of adjuvant radiotherapy for locally advanced gastric cancer following gastrectomy plus D2 lymphadenectomy has always been controversial. Esophagogastric junction (EGJ) adenocarcinoma, which is usually classified as gastric cancer in East Asia, often has a higher locoregional recurrence rate after operation because of its special anatomical characteristics. The aim of this study is to determine whether adjuvant radiotherapy can improve survival of locally advanced EGJ adenocarcinoma after D2 radical resection.Methods: In this phase III, randomized, open label, controlled trial, we plan to recruit 378 patients with Siewert type II and III adenocarcinoma of EGJ, who had undergone transabdominal radical surgery and D2 lymphadenectomy, and were divided into pathological stage IIB to IIIC. All patients will be randomized 1:1 to receive either adjuvant chemotherapy alone (control group) or adjuvant chemotherapy plus chemoradiotherapy (experimental group). Patients allocated to control group will receive eight cycles of S-1 plus oxaliplatin (SOX), while experimental group will receive two cycles of SOX followed by 45-Gy RT combined with S-1 and four additional cycles of SOX. The primary endpoint is three-year disease free survival rate (DFS). The secondary endpoints are three-year overall survival rate (OS), three-year locoregional recurrence free survival rate (LRFS), three-year distant metastasis free survival rate (DMFS), and quality of life (QoL).Discussion: In the past, the adjuvant treatment of EGJ adenocarcinoma need to draw on the experience of esophageal adenocarcinoma or gastric adenocarcinoma. In this study, EGJ adenocarcinoma is considered as an independent disease, and the conclusion will provide evidence for optimal adjuvant therapy of locally advanced EGJ adenocarcinoma after D2 radical resection.Trial registration: ClinicalTrials.gov, NCT03973008. Registered on June 1, 2019.

Masatinib mesylate in imatinib-naive locally advanced or metastatic gastrointestinal stromal tumor (GIST): Results of the French Sarcoma Group phase II trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 10507-10507
Author(s):  
A. Le Cesne ◽  
J. Blay ◽  
N. B. Bui ◽  
O. Bouché ◽  
A. Adenis ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Kinase Inhibitor ◽  
Metabolic Response ◽  
Locally Advanced ◽  
Phase Iii ◽  
Line Treatment ◽  
Juxtamembrane Region ◽  
Best Response ◽  
Advanced Gist

10507 Background: Masitinib mesylate (AB1010, AB Science, Paris, France) is a novel protein tyrosine kinase inhibitor which, in vitro, has greater activity and selectivity than imatinib mesylate against bith wild-type c-Kit receptor and its mutated form in the juxtamembrane region. Masatinib also inhibits PDGFR and FGFR3. This multicenter phase II study evaluated the efficacy and safety of masatinib as a first-line treatment of advanced GIST. Methods: Imatinib-naïve patients with inoperable, locally advanced or metastatic GIST received oral masatinib (7.5 mg/kg/day) until progression, refusal or toxicity. A Simon “minimax two stage” design was used. Efficacy variables included response rate at two months, best response according to RECIST, disease control rate (DCR), metabolic response rate and progression free survival (PFS). Results: 30 patients with a median age of 58 years (60% of males) were included from June 2005 to April 2007 in five French institutions. The most frequent relevant grade 3 toxicities were rash (10%), neutropenia (7%) and abdominal pain (7%). One patient presented a grade 4 skin exfoliation. Three patients discontinued treatment due to suspected toxicity. At two months, the response rate was 20% (6/30 patients) according to RECIST (DCR of 98.7%, 29/30 patients) and 84.6% (11/13 evaluable patients) according to FDG-PET response criteria. After a median follow-up of 23.7 months, there were 6.7% of CR, 43.3% of PR, 46.7% of SD and 3.3% of PD as best response (DCR of 96.7%). Mean time to response was 5.7 months (0.8 to 23.3 months). The median PFS was 27.2 months with PFS rates of 68.8% at 1 year and 60.2% at 2 years. Up to date, all but one patient are alive (one patient died of post-surgical complications, unrelated to treatment). Mutational analyses of the patients’tumors are ongoing. Conclusions: The results observed with masatinib compare favorably with those reported with imatinib in front-line treatment of advanced GIST both in term of safety and efficacy and support the initiation of a phase III randomized clinical trial. [Table: see text]

A phase I dose-escalation trial of TH-302 with nab-paclitaxel and gemcitabine in patients with locally advanced or metastatic pancreatic adenocarcinoma.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. TPS505-TPS505
Author(s):  
Anthony J. Olszanski ◽  
Andrea Wang-Gillam ◽  
Eunice Lee Kwak ◽  
Kamal Nazzal ◽  
Fazal Mehdi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Pancreatic Adenocarcinoma ◽  
Dose Escalation ◽  
Response Rate ◽  
Metabolic Response ◽  
Locally Advanced ◽  
Phase Iii ◽  
Brca1 And Brca2 ◽  
Open Label

TPS505 Background: TH-302 is a hypoxia-activated, nitroimidazole-linked prodrug of bromo-isophosphoramide mustard (Br-IPM), which is released under hypoxic conditions. TH-302 is currently being studied in combination with gemcitabine (G) in a phase III trial in patients (pts) with advanced pancreatic adenocarcinoma (PDAC) (NCT01746979). Encouraging preclinical activity of TH-302 plus nab-paclitaxel (nab-P) and G provides a rationale for further study of this triplet (Sun JD et al, AACR Special Conference on Pancreatic Cancer 2014; abstract #B88). Methods: Clinical trial: NCT02047500. Open-label, phase I, dose-escalation trial of TH-302 plus nab-P and G in pts with previously untreated locally advanced or metastatic PDAC. Dose escalation: 3 + 3 design with one of 3 planned dose levels of TH-302 (170, 240 and 340 mg/m2) on days 1, 8, and 15 of a 28-day cycle, plus nab-P 100–125 mg/m2 followed by G 800–1,000 mg/m2. Expansion cohort (n≥15): TH-302 at the recommended phase II dose (RP2D) with nab-P 100–125 mg/m2 followed by G 800–1,000 mg/m2. Treatment will be continued until disease progression or intolerable toxicity. Primary objectives: To evaluate safety and tolerability, define the maximum tolerated dose and determine the RP2D of TH-302 in combination with nab-P/G. The primary endpoint is no. of pts with dose-limiting toxicities during the first 28 days. Secondary objectives: To evaluate overall safety of the triplet regimen, metabolic response rate using EORTC criteria for 18F-FDG PET, CA19–9 response rate (defined as >50% decline from baseline), and RECIST response rate of TH-302 plus nab-P/G. The pharmacokinetic (PK) profile of TH-302 and Br-IPM in the plasma of pts will also be evaluated, as will the effect of TH-302 on the PK of nab-P, and vice versa. Exploratory analyses include the association of pharmacogenomic markers, such as CYP2C9, BRCA1 and BRCA2, with PK, safety and efficacy. The association of potential hypoxia biomarkers (CA IX, GLUT1, VEGF, osteopontin) with antitumor activity will also be explored. The trial is in progress; 7 of an estimated 48 planned pts have been recruited (trial start Jan 2014, estimate end Aug 2016). Clinical trial information: NCT02047500.

Short- and long-term outcomes of neoadjuvant-synchronus S-1+radiotherapy for locally advanced rectal cancer: Multicenter phase II study.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 720-720
Author(s):  
Takahiro Hiratsuka ◽  
Tomonori Akagi ◽  
Kentaro Nakajima ◽  
Shinichiro Empuku ◽  
Tomotaka Shibata ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Survival Rate ◽  
Response Rate ◽  
Locally Advanced ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Pathological Response ◽  
Complete Treatment ◽  
Grade 3

720 Background: Fluorouracil-based chemoradiotherapy (CRT) is regarded as a standard perioperative treatment in locally advanced rectal cancer. We investigated the efficacy and safety of substituting fluorouracil with the oral prodrug S-1. Methods: A multi-institutional (17 specialized centers), interventional phase II trial, was conducted from April 2009 to August 2011. For inclusion, patients must fulfill the following requirements before neoadjuvant CRT: (i) histologically proven rectal carcinoma; (ii) tumor located in the rectum (upper, lower); (iii) cancer classified as T3-4, N0–3 and M0; Two cycles of neoadjuvant CRT with S-1 (100 mg/m2 on days 1-5, 8-12, 22-26, and 29-33) was administered, and irradiation (total 45Gy/25fr, 1.8Gy/day, on days 1-5, 8-12, 15-19, 22-26, and 29-33) was performed. Total mesorectal excision was performed during the 4th and 8th week after the end of the neoadjuvant CRT. The primary endpoint is rate of complete treatment of neoadjuvant CRT. Secondary endpoints are response rate of neoadjuvant CRT, short-term clinical outcomes, rate of curative resection, and pathological response (grade2/3). Results: This trial included 37 patients (clinical StageIIA: 8, IIIB: 19, IIIC: 10; tumor located in the upper rectum; 4, the lower rectum; 33). A complete treatment of neoadjuvant CRT was found in 86.5% of patients (95%CI;75.5-97.5%), and an adverse event (grade 3/4) occurred in 4 patients(11.1%). Response rate (PR/CR;RECIST 1.0) was 56.8% (95%CI; 40.8-72.7%), and pathologic response rate (grade2/3) was 48.6% (95%CI; 32.5-64.8%). The median operating time was 448.5 min (IQR 340.5-505.5), and median blood loss was 422.5 mL (IQR 182.5-1125). Grade 3-4 postoperative complications occurred in 6 (16.7%) patients. The most common grade 3 or 4 postoperative complication was anastomotic leakage (2 [5.6%]). The 3-year overall survival rate was 88.5%. The 3-year disease free survival rate was 70.9%. Median length of follow-up was 42 months. Conclusions: A neoadjuvant-synchronus S-1+Radiotherapy for locally advanced rectal cancer is feasible in terms of pathological response, adverse events, accompany with favorable long-term outcome. Clinical trial information: 03396.

scholarly journals Efficacy and safety of concurrent chemoradiotherapy with or without Nimotuzumab in unresectable locally advanced squamous cell carcinoma of head and neck: Prospective comparative study - ESCORT-N study

2019 ◽  
Vol 08 (02) ◽  
pp. 108-111
Author(s):  
Ashok Kumar ◽  
Nilotpal Chakravarty ◽  
Sharad Bhatnagar ◽  
G. S. Chowdhary
Keyword(s):  
Squamous Cell Carcinoma ◽  
Survival Rate ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Tumor Response ◽  
Response Rate ◽  
Locally Advanced ◽  
Advanced Squamous Cell Carcinoma ◽  
Efficacy And Safety

Abstract Background: Nimotuzumab is an anti-epidermal growth factor receptor monoclonal antibody which can be added to chemoradiotherapy (CRT) to improve efficacy for management of locally advanced squamous cell carcinoma of the head and neck (LASCCHN). We prospectively evaluated the efficacy and safety of nimotuzumab with CRT for LASCCHN and compared with CRT alone. Materials and Methods: In this prospective study, 29 LASCCHN (Stage III–IVb) patients received Nimotuzumab plus CRT or CRT alone. Treatment included six cycles of cisplatin (40–50 mg/week) or carboplatin (area under the curve-based), nimotuzumab (200 mg/week), and radiotherapy (60–70 Gy). Tumor response was evaluated as per response evaluation criteria in solid tumors criteria. MoS was estimated using the Kaplan–Meier method. Toxicity and adverse events (AE's) were assessed as per CTCAE v 4.0. Results: At 24 weeks after completion of treatment, the tumor response rate (complete response, partial response, stable disease) was 53.3% and 35.7% favoring nimotuzumab arm while progression of disease was 40% and 35.7% in Nimotuzumab plus CRT and CRT groups, respectively. However, the objective response rate was 57% and 30% in favor of nimotuzumab arm. At median follow-up of 45.5 months, MoS was 33 months in Nimotuzumab plus CRT and 27 months in CRT group. The 5-year survival rate was 33.3% in Nimotuzumab plus CRT versus 7.1% in CRT group. Nimotuzumab was observed to be safe with no additional AE's such as hypersensitivity, hypomagnesemia, and allergic reaction was reported. Conclusion: Addition of Nimotuzumab to standard CRT showed improved survival rate in unresectable, LASCCHN patients without producing additional toxicity.

scholarly journals Effectiveness and tolerability of nimotuzumab in unresectable, locally advanced/metastatic esophageal cancer: Indian hospital-based retrospective evidence

2019 ◽  
Vol 08 (02) ◽  
pp. 112-115
Author(s):  
Sundaram Subramanian ◽  
Nithya Sridharan ◽  
V. Balasundaram ◽  
Sameer Chaudhari
Keyword(s):  
Squamous Cell Carcinoma ◽  
Esophageal Cancer ◽  
Survival Rate ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Tumor Response ◽  
Response Rate ◽  
Locally Advanced ◽  
Tumor Response Rate

Abstract Context: Epidermal growth factor receptor (EGFR) is overly expressed in esophageal squamous cell carcinoma (ESCC) and is important prognostic and predictive biomarker. Nimotuzumab is a humanized anti-EGFR monoclonal antibody and has documented promising clinical outcomes and survival rates in various solid tumors with high EGFR expression. Aims: Attempt to fill gap on paucity of data in India on the efficacy of Nimotuzumab in the treatment of locally advanced/metastatic ESCC. Settings and Design: Hospital records of 15 patients with unresectable, locally advanced/metastatic esophageal cancers, histologically confirmed squamous cell carcinoma being treated with Nimotuzumab along with standard treatments from October 2006 to November 2016 were retrospectively analyzed. Subjects and Methods: The tumor response rate and overall survival (OS) were analyzed. All patients were assessed for toxicity and adverse events (AEs) as per Common Terminology Criteria for Adverse Events (CTCAE) v4. Results: Majority had lower thoracic esophageal cancer. Tumor response rate observed was as follows 33% had a complete response, 67% had a partial response, and objective response rate was 100%. Survival rate at 1-, 3-, and 5-year was 58.33%, 29.17%, and 29.17%, respectively. Median OS was 26.8 months (95% confidence interval, 2.63–not reached). No Grade III or Grade IV AEs were observed. No added toxicity was observed due to nimotuzumab.Conclusions: Nimotuzumab combined with standard treatment in locally advanced/metastatic ESCC improved the survival rate and achieved a better tumor response rate without accumulation of toxicity and was well tolerated.

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