Nutritional outcomes after radiotherapy target volume reduction for nasopharyngeal cancer: a Phase III trial

2020 ◽  
Author(s):  
Li Xiang ◽  
Jin-Feng Rong ◽  
Hao-Wen Pang ◽  
Huai-Lin He ◽  
Yue Chen ◽  
...  
Keyword(s):  
Nutritional Status ◽  
Gross Tumor Volume ◽  
Tumor Volume ◽  
Nasopharyngeal Cancer ◽  
Intensity Modulated Radiotherapy ◽  
Target Volume ◽  
Phase Iii ◽  
Poor Nutritional Status ◽  
Group A ◽  
Group B

Aim: This study aimed to assess the nutritional status of patients with locoregionally advanced nasopharyngeal cancer, for whom intensity-modulated radiotherapy (IMRT) was planned using their pre- or post-induction chemotherapy (IC) nasopharyngeal gross tumor volume. Materials & methods: Two-hundred twelve cases of stage III–IVb nasopharyngeal cancer were randomized into groups A (n = 97) and B (n = 115). IMRT was planned for groups A and B using pre-IC and post-IC images, respectively. Results: There was a significant decrease in the nutritional parameters of group B compared with those of group A during radiotherapy. Multivariate analysis indicated that the T stage and nasopharyngeal gross tumor volume IMRT-planning protocol were prognostic factors of poor nutritional status. Conclusion: Decreasing the IMRT target volume through IC can improve nutritional status.

scholarly journals Tumor Size at Magnetic Resonance Imaging Association With Lymph Node Metastasis and Lymphovascular Space Invasion in Resectable Cervical Cancer: A Multicenter Evaluation of Surgical Specimens

2018 ◽  
Vol 28 (8) ◽  
pp. 1545-1552 ◽  
Author(s):  
Xiao-li Chen ◽  
Guang-wen Chen ◽  
Guo-hui Xu ◽  
Jing Ren ◽  
Zhen-lin Li ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Gross Tumor Volume ◽  
Tumor Volume ◽  
Figo Stage ◽  
Maximum Diameter ◽  
Resonance Imaging ◽  
Node Metastasis ◽  
Group A ◽  
Group B ◽  
Lymphovascular Space Invasion

ObjectiveTo determine whether gross tumor volume (GTV) and the maximum diameter of resectable cervical cancer at magnetic resonance imaging (MRI) could predict lymph node metastasis (LNM) and lymphovascular space invasion (LVSI).Materials and MethodsA total of 315 consecutive patients with cervical cancer were retrospectively identified. Gross tumor volume and the maximum diameter of tumor were evaluated on MRI. Univariate and multivariate logistic regression analyses were performed to determine whether tumor size could predict LNM and LVSI. Cutoffs of GTV, maximum diameter, and the International Federation of Gynecology and Obstetrics (FIGO) classification of tumor were first investigated in 255 patients (group A) and then validated in an independent cohort of 60 patients (group B) using area under the receiver operating characteristic curve (AUC) analysis for predicting the presence of LNM and LVSI.ResultsUnivariate analysis showed that GTV and the maximum diameter of tumor could predict LNM and LVSI (all P < 0.0001). Multivariate analyses indicated GTV as an independent risk factor of LNM and LVSI (all P < 0.0001). In group A, GTV, the maximum diameter, and the FIGO stage could identify LNM (AUC, 0.813, 0.741, and 0.69, respectively) and LVSI (AUC, 0.806, 0.751, and 0.684, respectively). In group B, GTV, the maximum diameter, and the FIGO stage could help identify LNM (AUC, 0.902, 0.825, and 0.759, respectively) and LVSI (AUC, 0.771, 0.748, and 0.700, respectively).ConclusionsGross tumor volume and the maximum diameter of resectable cervical cancer at MRI demonstrated capability in predicting LNM and LVSI, which were more accurate than FIGO stage.

scholarly journals Interobserver variability in target volume delineation in definitive radiotherapy for thoracic esophageal cancer: a multi-center study from China

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Xiao Chang ◽  
Wei Deng ◽  
Xin Wang ◽  
Zongmei Zhou ◽  
Jun Yang ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Gross Tumor Volume ◽  
Tumor Volume ◽  
Interobserver Variability ◽  
Target Volume ◽  
Thoracic Esophageal Cancer ◽  
Target Volume Delineation ◽  
Cancer Centers ◽  
Definitive Radiotherapy ◽  
Volume Delineation

Abstract Purpose To investigate the interobserver variability (IOV) in target volume delineation of definitive radiotherapy for thoracic esophageal cancer (TEC) among cancer centers in China, and ultimately improve contouring consistency as much as possible to lay the foundation for multi-center prospective studies. Methods Sixteen cancer centers throughout China participated in this study. In Phase 1, three suitable cases with upper, middle, and lower TEC were chosen, and participants were asked to contour a group of gross tumor volume (GTV-T), nodal gross tumor volume (GTV-N) and clinical target volume (CTV) for each case based on their routine experience. In Phase 2, the same clinicians were instructed to follow a contouring protocol to re-contour another group of target volume. The variation of the target volume was analyzed and quantified using dice similarity coefficient (DSC). Results Sixteen clinicians provided routine volumes, whereas ten provided both routine and protocol volumes for each case. The IOV of routine GTV-N was the most striking in all cases, with the smallest DSC of 0.37 (95% CI 0.32–0.42), followed by CTV, whereas GTV-T showed high consistency. After following the protocol, the smallest DSC of GTV-N was improved to 0.64 (95% CI 0.45–0.83, P = 0.005) but the DSC of GTV-T and CTV remained constant in most cases. Conclusion Variability in target volume delineation was observed, but it could be significantly reduced and controlled using mandatory interventions.

The association of renal function with safety and efficacy of cisplatin plus S-1 (CS) therapy and docetaxel plus cisplatin plus S-1 (DCS) therapy in patients with advanced gastric cancer (AGC): An additional analysis of JCOG1013.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16035-e16035
Author(s):  
Shuichi Hironaka ◽  
Ryo Sadachi ◽  
Nozomu Machida ◽  
Satoru Iwasa ◽  
Yasuhide Yamada ◽  
...  
Keyword(s):  
Renal Function ◽  
Adverse Events ◽  
Objective Response ◽  
Exploratory Analysis ◽  
Phase Iii ◽  
Fixed Dose ◽  
Hematological Toxicity ◽  
Significant Difference ◽  
Group A ◽  
Group B

e16035 Background: A phase III study, JCOG1013, did not show the superiority of docetaxel plus cisplatin plus S-1 (DCS) to cisplatin plus S-1 (CS) in overall survival (OS) (Yamada Y, Lancet GH 2019). It is known that cisplatin and gimeracil (an inhibitor of dihydropyrimidine dehydrogenase contained in S-1) are excreted in urine. We previously reported (abstr 197, ASCO-GI 2021) exploratory analysis of JCOG1013 which showed creatinine clearance (CrCl) was associated with safety (Grade [G]4 hematological toxicity for CS, and G3-4 non-hematological toxicity for CS and DCS), but not with efficacy in either group. Here, we report the additional detail results of this exploratory analysis. Methods: Among 741 participants in JCOG1013, patients with serum creatinine level < 1.2 mg/dL were included in this analysis and categorized by CrCl and treatment into A1 (CrCl ≥ 80 mL/min, CS), A2 (60 < CrCl < 80, CS), A3 (CrCl < 60, CS), B1 (CrCl > 80, DCS), B2 (60 < CrCl < 80, DCS), and B3 (CrCl < 60, DCS). The dose (mg/m2) of C/S was 60/80 regardless renal function in group A (A1, A2 and A3), and that of D/C/S was adjusted in group B as follows: 40/60/80 in B1, 40/50/80 in B2, and 40/40/65 in B3. Adverse events, OS, progression-free survival (PFS), and objective response rate (ORR) were compared by CrCl in group A (A1 vs. A2 vs. A3) and group B (B1 vs B2 vs B3), respectively. Results: Of 723 pts (169/136/57 in A1/A2/A3 and 170/138/53 in B1/B2/B3), the median CrCl (mL/min) was 94.1/71.9/53.4 in A1/A2/A3 and 98.2/70.0/55.6 in B1/B2/B3. The relative dose intensity of C/S was 90.4/75.3%, 87.8/74.9% and 85.7/72.8% in A1, A2 and A3, and that of D/C/S was 87.5/77.7/74.9%, 85.8/61.2/72.7% and 87.8/49.4/58.3% in B1, B2 and B3. The incidence of G4 white blood cell decreased, G4 neutrophil count decreased, and G3-4 anorexia were 1.2/4.4/9.3% (P < 0.01), 4.8/11.1/18.5% (P < 0.01), 14.4/28.1/28.6% (P < 0.01) in A1/A2/A3, and 1.8/3.0/4.0% (P = 0.36), 27.3/24.8/20.0% (P = 0.28), 22.4/29.3/32.0% (P = 0.11) in B1/B2/B3, respectively. No significant association between CrCl and other adverse events was observed either in CS or in DCS group. The median OS was 15.4/15.5/15.4 months in A1/A2/A3 (P = 0.89) and 15.3/13.7/13.7 months in B1/B2/B3 (P = 0.72). The median PFS was comparable among A1/A2/A3 (7.1/6.8/6.2 months, P = 0.88) and B1/B2/B3 groups (7.5/7.2/7.8 months, P = 0.85). ORR showed no significant difference in A1/A2/A3 (58.9/57.8/46.9%, P = 0.31) and B1/B2/B3 groups (62.0/61.5/51.5%, P = 0.36). Conclusions: Dose modification according to renal function in the DCS arm could control the increase of severe toxicities, which were observed frequently in patients with low renal function in patients receiving fixed dose of CS. Clinical trial information: 000007652.

Fluorouracil and leucovorin with or without interferon alfa-2b in advanced colorectal cancer: analysis of a prospective randomized phase III trial. Hellenic Cooperative Oncology Group.

1996 ◽  
Vol 14 (10) ◽  
pp. 2682-2687 ◽  
Author(s):  
P A Kosmidis ◽  
N Tsavaris ◽  
D Skarlos ◽  
D Theocharis ◽  
E Samantas ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Positive Impact ◽  
Performance Status ◽  
Final Analysis ◽  
Interferon Alfa ◽  
Phase Iii ◽  
Psychological Reactions ◽  
Group A ◽  
Group B

PURPOSE To investigate if double modulation of fluorouracil (5-FU) with leucovorin (folinic acid [FA]) and interferon alfa-2b (IFN 2b) improves responses and survival in comparison to single modulation of 5-FU with FA. PATIENTS AND METHODS One hundred six patients with histologically confirmed advanced colorectal cancer, measurable disease, and without previous chemotherapy were prospectively randomized into two groups. Patients in group A received 5-FU 450 mg/m2 as an intravenous bolus in the midinfusion of FA weekly. FA was given at a dose of 200 mg/m2 in 500 mL 0.9% normal saline solution in 2-hour infusion. Patients in group B received exactly the same regimen plus IFN 2b 5 million units subcutaneously three times weekly. RESULTS All patients were well balanced in both groups regarding age, sex, performance status, number, and site of metastasis. One hundred two patients were assessable. All patients have died. There was no difference in response between the two groups (7.8% v 9.8%). Median survival was 10.1 months in group A, and 7.2 months in group B (P = .00189). Median time to progression was 8.4 and 5.2 months, respectively (P = .00196). Overall, better performance status and older age had a positive impact on survival. Toxicity was the most important and catastrophic aspect of this study. Patients who received IFN 2b had significantly worse anemia, neutropenia, diarrhea, anorexia, weight loss, flu-like syndrome, and psychological reactions. CONCLUSION Based on this final analysis, the addition of IFN 2b to the combination of 5-FU and FA enhances toxicity and contributes to decreased survival.

scholarly journals PREVALENCE OF HEPATIC STEATOSIS AMONG CHILDREN AND ADOLESCENTS WITH CYSTIC FIBROSIS AND ITS ASSOCIATION WITH NUTRITIONAL STATUS

2019 ◽  
Vol 37 (4) ◽  
pp. 435-441
Author(s):  
Amanda Oliva Gobato ◽  
Ana Carolina Junqueira Vasques ◽  
Antonio Fernando Ribeiro ◽  
Roberto Massao Yamada ◽  
Gabriel Hessel
Keyword(s):  
Cystic Fibrosis ◽  
Nutritional Status ◽  
Children And Adolescents ◽  
Hepatic Steatosis ◽  
Statistical Tests ◽  
The Body ◽  
Significant Difference ◽  
Group A ◽  
The Mean ◽  
Group B

ABSTRACT Objective: To determine the prevalence of hepatic steatosis (HS) in children and adolescents with cystic fibrosis (CF) and associate it with nutritional status. Methods: Cross-sectional study with children and adolescents with CF diagnosis. Weight and height were used to calculate the body mass index (BMI) and subsequent classification of the nutritional status. The midarm circumference (MAC), triceps skinfold thickness (TSF) and midarm muscle circumference (MAMC) were used to evaluate body composition. Abdominal ultrasonography was performed for diagnosis of HS. The statistical tests used were Student’s t test, Mann-Whitney test and chi-square test with significance level of 5%. Results: 50 patients with CF were evaluated, 18 (36%) were diagnosed with HS (Group A) and 32 (64%) without HS (Group B). The mean age of Group A was 13,2±4,9 years old and Group B 11,7±4,9; for BMI, the value for Group A was 18,0±4,1 and Group B was 15,7±3,8; the TSF of Group A was 8,4±3,5 mm and Group B was 7,0±2,5 mm. For these variables, there was no significant difference between the groups. The mean of MAC and MAMC differed significantly between the groups, being higher in the HS group, with p values of 0,047 and 0,043. Conclusions: The frequency of HS in patients with CF is high and it is not related to malnutrition, according to the parameters of BMI, TSF and MAMC. The values of MAC and MAMC indicated a greater reserve of muscle mass in patients with HS.

Cyberknife stereotactic radiosurgery in patients with primary hepatocellular carcinoma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4645-4645
Author(s):  
K. Kang ◽  
B. Choi ◽  
H. Jang ◽  
S. Bae ◽  
M. Ryu ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Stereotactic Radiosurgery ◽  
Complete Response ◽  
Treated Group ◽  
Target Volume ◽  
Primary Treatment ◽  
Primary Hepatocellular Carcinoma ◽  
Ulcer Bleeding ◽  
Group A ◽  
Group B

4645 Background: Conventional radiotherapy has historically played a limited role in the primary treatment of hepatocellular carcinoma (HCC). This study evaluated the effect of Cyberknife stereotactic radiosurgery (SRS) with for both for small primary non-resectable HCC, and for advanced HCC with portal vein tumor thrombosis (PVTT). Methods: From March 2004 to March 2005, thirty one patients with HCC were treated Cyberknife SRS was used for 32 lesions in patients with SRS for primary HCC. There was performed in 22 patients (23 lesions) with targeting to the primary HCC was treated (Group A), and in 9 patients with targeting to the PVTT was treated (Group B). The total SRS doses treated were 30–39 Gy (median, 36 Gy) to the 70–85%, 3 fractions and the target volume was of 3.6–57.3 cc (median, 25.2 cc). Results: The median follow up was 10.5 months. A complete response (CR) was achieved in 10 lesions, a partial response (PR) in 13 lesions, stable disease was noted in 6 lesions, and disease progression in 3 lesions. The response rate (CR+PR) was 71.9% (group A: 82.6%, group B: 44.4%). The level of serum alpha-fetoprotein after the treatment was decreased significantly in 17 patients (54.8%) (group A: 54.5%, group B: 55.5%). Complications were observed in 15 patients, among them, greater than grade 3 complication was observed in two patients of group A (gastric ulcer bleeding (1), liver necrosis (1)). Conclusions: These results suggest that Cyberknife SRS could be considered as an effective and safe treatment for primary HCC. For PVTT, Cyberknife SRS as the only curative tool, and produced acceptable local control in this study. No significant financial relationships to disclose.

Randomized phase III study of irinotecan and 5-FU/FA with or without cetuximab in the first-line treatment of patients with metastatic colorectal cancer (mCRC): The CRYSTAL trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4000-4000 ◽  
Author(s):  
E. Van Cutsem ◽  
M. Nowacki ◽  
I. Lang ◽  
S. Cascinu ◽  
I. Shchepotin ◽  
...  
Keyword(s):  
Response Rate ◽  
Performance Status ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Ecog Performance Status ◽  
Skin Reactions ◽  
Group A ◽  
Group B ◽  
First Line Treatment

4000 Background: Cetuximab in combination with irinotecan-based regimens has proven activity in previously-treated patients (pts) with mCRC. The present trial investigated the effectiveness of cetuximab in combination with standard FOLFIRI compared with FOLFIRI alone in the first-line treatment of pts with epidermal growth factor receptor (EGFR)-expressing mCRC. Methods: Pts were randomized 1:1 to receive either cetuximab (400 mg/m2 initial dose then 250 mg/m2/week [w]) plus FOLFIRI q 2 w (irinotecan 180 mg/m2, FA 400 mg/m2, 5-FU bolus 400 mg/m2, 5-FU infusion 2,400 mg/m2 over 46 hours) (Group A) or FOLFIRI alone (Group B). The primary endpoint was progression-free survival (PFS), with secondary endpoints of overall survival (OS), response rate (RR), disease control rate and safety. 633 events were required to statistically differentiate PFS between groups with 80% power. Results: Between August 2004 and October 2005, 1,217 pts were randomized, 608 to Group A and 609 to Group B (60% male, median age 61 [19–84], ECOG performance status: 0=54%; 1=43.5%; 2=3.5%). Median PFS was significantly longer for Group A compared to Group B (8,9 months [8 - 9,5] for Group A vs. 8 months [7.6 - 9] for Group B, p=0.036). Response Rate was also significantly increased by cetuximab (46.9% vs. 38.7%, p=0.005). Treatment was generally well tolerated with neutropenia (26.7% Group A, 23.3% Group B), diarrhea (15.2% and 10.5% respectively) and skin reactions (18.7% and 0.2% respectively) being the most common grade 3/4 adverse events. Conclusions: Cetuximab in combination with FOLFIRI significantly increases response rate and significantly prolongs PFS in the first-line treatment of pts with mCRC, reducing the relative risk of progression by approximately 15%. Treatment-related side effects of cetuximab in combination with FOLFIRI were as expected, with diarrhea being moderately and skin reactions significantly more frequent as compared to FOLFIRI alone. [Table: see text]

Randomized phase III study comparing FOLFOX + bevacizumab versus folfoxiri + bevacizumab (BEV) as 1st line treatment in patients with metastatic colorectal cancer (mCRC) with ≥3 baseline circulating tumor cells (bCTCs).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3507-3507 ◽  
Author(s):  
Javier Sastre ◽  
Jose María Vieitez ◽  
Maria Auxilidora Gomez-España ◽  
Silvia Gil Calle ◽  
Antonieta Salud Salvia ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Adequate Treatment ◽  
Poor Prognostic Factor ◽  
Efficacy Analysis ◽  
Secondary Endpoints ◽  
Group A ◽  
Phase Iii Study ◽  
Group B

3507 Background: FOLFOXIRI+BEV has demonstrated a survival benefit compared with FOLFIRI plus BEV (TRIBE Lancet Oncol 2015) in first-line mCRC. Nevertheless, due to its safety profile, this schedule is not recommended for all pts. In addition, we have showed that the detection of ≥3 bCTCs is a poor prognostic factor for survival (MACRO The Oncologist 2012). The VISNU-1 trial compares FOLFOX + BEV vs FOLFOXIRI + BEV in pts with mCRC and ≥3 bCTCs. Progression-free survival (PFS) is the primary endpoint. Secondary endpoints included overall response rate (ORR) and overall survival (OS). Methods: This is an open, multicentric, randomized phase III trial. Patients with mCRC younger than 70 years, ECOG 0-1 were randomized to FOLFOX+BEV (arm A) or FOLFOXIRI+BEV (arm B), stratified per KRAS mutation (mutated vs WT) and number of involved organs (1 vs >1). Results: 349 pts were included in the ITT population; 177 in group A and 172 in group B. Characteristics of the pts, molecular profiling and safety analysis have been previously presented at ASCO 2018 and showed that this schedule had an acceptable toxicity profile. Efficacy analysis in the ITT population is shown in the table. Conclusions: In this population with very bad prognosis, our study met its primary endpoint. Pts who received FOLFOXIRI + Bev benefit for a statistically significative PFS and ORR. OS showed a trend of benefit in the experimental arm. According to these results, FOLFOXIRI-Bev could be considered an adequate treatment option for pts with mCRC and ≥3 bCTCs. Clinical trial information: 2012-000846-37. [Table: see text]

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