Impact of p16 status on the QOL effects of chemoradiation for locally advanced oropharynx cancer: Results of TROG 02.02.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 5571-5571 ◽  
Author(s):  
Jolie Ringash ◽  
Richard Fisher ◽  
Lester J. Peters ◽  
Brian O'Sullivan ◽  
Andy Trotti ◽  
...  
Keyword(s):  
Oropharyngeal Cancer ◽  
Locally Advanced ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Significant Difference ◽  
Ecog Ps ◽  
The Impact ◽  
Subsequent Time Point

5571 Background: We report the impact of p16 status on quality of life (QOL) for patients with stage III or IV (excluding T1-2N1 and M1) squamous cell carcinoma of the oropharynx (OPC) treated with concurrent chemoradiotherapy in a large international phase III trial (TROG 02.02/HeadSTART). Methods: The 861 patients accrued received definitive radiotherapy (RT) (70 Gy/7 weeks) concurrently with 3 cycles of either cisplatin (100mg/m2) or cisplatin (75 mg/m2) plus tirapazamine (290 mg/m2/day) by random assignment, as previously described. QOL was measured with the FACT-H&N at baseline, 2,6,12, 23 and 38 months. No significant difference in overall or subscale QOL score change from baseline was observed between arms at any subsequent time point; results for the oropharynx subgroup by p16 status are reported for both treatment arms combined. Results: Of 853 eligible participants, 465 had OPC, for whom p16 status could be determined in 206. Of 179 who received adequate RT (≥ 60 Gy, no major deviations) and completed baseline QOL, 104 were p16+ and 79 were p16-. p16+ patients had better baseline ECOG PS, lower T-category, higher N-category, were younger and were less likely to be current smokers. Baseline mean FACT-H&N score was statistically and clinically significantly better in p16+ patients (111 vs. 102, p=0.001). The drop in QOL from baseline to 2 months was more severe in p16+ cases (-20.4 vs -9.1, p=0.001), resulting in an equalization of 2 month scores (p16+: 90.6, p16-: 93.6, p=0.16). At 6 and 12 months post-treatment, no difference in score changes from baseline by p16 status was seen (6 mo, p16+: -6.2, p16 -:-1.2, p=0.22; 12 mo, p16 +: -0.3, p16 -: +2.0, p=0.82). Conclusions: p16 associated oropharyngeal cancer has been shown to be a distinct entity with different demographic features. In our study, such patients exhibited better baseline QOL and a more severe drop immediately after treatment, but did not differ in long-term QOL response to the effects of aggressive concurrent chemoradiation. Given the favorable prognosis of p16-associated oropharyngeal cancer, efforts to reduce the QOL burden of treatment are warranted.

Quality of life in patients with locally advanced head and neck cancer undergoing chemoradiation with once-a-week versus once-every-three-weeks cisplatin.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12092-12092
Author(s):  
Nandini Sharrel Menon ◽  
Vanita Noronha ◽  
Amit Joshi ◽  
Vijay Maruti Patil ◽  
Atanu Bhattacharjee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck ◽  
Locally Advanced ◽  
Phase Iii ◽  
Locoregional Control ◽  
Advanced Head ◽  
Significant Difference ◽  
Eortc Qlq ◽  
The Impact

12092 Background: This trial was conducted to compare the efficacy of low dose once-a-week cisplatin with once-every-3-weeks cisplatin with radiation in locally advanced head and neck squamous cell carcinoma (LAHNSCC). The current analysis focuses on the quality of life (QoL) of patients in this trial. Methods: In this phase III randomized trial, patients with stage III or IV non-metastatic LAHNSCC were randomized to receive cisplatin 30 mg/m2 once a week or cisplatin 100 mg/m2 once every 3 weeks concurrently with curative intent radiotherapy. The primary endpoint was locoregional control. QoL was a key secondary endpoint. QoL was assessed using the EORTC QLQ-C30 (v.3) and EORTC QLQ-H&N35 (v.1). QoL data were assessed at baseline and days 22 and 43 during treatment; at the end of chemoradiation and at each follow-up. The linear mixed effects model was used for longitudinal analysis of QoL domains to determine the impact of treatment (arm) and time on QoL scores. Results: Three hundred patients were enrolled, 150 in each arm. QoL data from 283 patients with at least one assessable questionnaire were analyzed. The pretreatment QoL scores were similar in both the arms in all domains. There was no significant difference in the global health status/QoL with respect to the treatment arm ( P =0.608) or time ( P=0.0544 ). There was no significant difference in the longitudinal QoL scores between the two treatment arms in all domains except the physical function ( P= .0074), constipation ( P= .0326), trouble with social contact ( P= .0321) and sexuality ( P= .0004). There was a decline in the QoL scores in all domains in both arms during treatment. After completion of treatment, the QoL scores started improving steadily up to 1 year and plateaued thereafter in both arms. Conclusions: The use of once-every-three weeks cisplatin significantly improved the locoregional control without adversely impacting the quality of life as compared to once-a-week cisplatin in combination with radical radiotherapy in locally advanced HNSCC. Clinical trial information: CTRI/2012/10/ 003062. .

Time to secondary resistance (TSR) after interruption of imatinib: Updated results of the prospective French Sarcoma Group randomized phase III trial on long-term survival

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 10508-10508
Author(s):  
F. Duffaud ◽  
I. Ray-Coquard ◽  
B. Bui ◽  
A. Adenis ◽  
M. Rios ◽  
...  
Keyword(s):  
Treatment Interruption ◽  
Phase Iii ◽  
Tumor Control ◽  
Term Survival ◽  
Secondary Resistance ◽  
Phase Iii Trial ◽  
Resistance Decrease ◽  
The Impact

10508 Background: We previously demonstrated that imatinib mesylate (IM, Gleevec/Glivec; Novartis Pharma) must not be interrupted after 1 and 3 years (yr) in responding patients (pts) and has to be given continuously until disease progression (PD) or intolerance. The impact of IM re-introduction at progression remains unknown regarding the impact of the interruption on the TSR. Methods: This prospective national multicenter BFR14 study was initiated in June 2002. After 1, 3, and 5 yrs of IM 400mg/day, pts free from progression were randomly offered to continue (C arm) or interrupt (I arm) IM. Pts allocated to the I arm could restart IM (same dose) in case of PD. Primary endpoint was PFS. Pts declining randomization proceed with IM. Results: As of December 2008, 415 pts were included in this trial. Fifty-eight, 50 and 12 (ongoing) non progressive pts at 1, 3 and 5 yrs respectively were randomized in the I and C arm. Pt characteristics were well balanced between the two arms. The median time to progression (TTP) were 7.3 months (m) (rate of relapse: 91% of pts) and 9.4 m (rate of relapse: 84%) in the I arms after 1 and 3 years of treatment. In contrast the median TTP were 31.4 m and not reached in the C arms after 1 and 3 yrs of IM treatment respectively. IM reintroduction in the I arm after a re-progression allowed again a tumor control in 93% (43/46) of pts. The median follow-up from randomization is 56 m and 25 m at 1 and 3 yrs respectively. TSR after randomization to IM (first progression in the C arm, 2nd progression in the I arm) was not significantly different between the two arms (the 2-yrs TSR is similar in both arms 63% and 62% in the I and C arm respectively for the 1-yr randomization, 83.5% and 84.3% for the 3-yr randomization) but the rate of secondary resistance decrease over time in both arms: 40% or relapse in the 2 yrs following the 1 yr randomization vs less than 20% or relapse in the 2 yrs following the 3-yrs randomization. Conclusions: The majority of responding pts relapsed when IM was stopped after 1 and 3 yrs of treatment but response is reinduced in 93% of patients after IM reintroduction. TSR was not significantly affected by treatment interruption in this series of pts. [Table: see text]

Gemcitabine (G) plus nab-paclitaxel (nab-P) plus chemoradiation (CRT) in locally advanced pancreatic cancer (LAPC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14714-e14714
Author(s):  
Olugbenga Olanrele Olowokure ◽  
Ivan Dario Bedoya ◽  
Michelle Lynn Mierzwa ◽  
Maria Patricia Torregroza ◽  
Alok kumar Dwivedi ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Categorical Variables ◽  
Rank Test ◽  
Nccn Guidelines ◽  
Prior Therapy ◽  
Significant Difference ◽  
Ecog Ps ◽  
The Impact

e14714 Background: 30-40 % of PC pts present with LAPC. Optimal management remains controversial. Current NCCN guidelines, suggests clinical trial, FOLFIRINOX, G, G based combination therapy, chemo followed by CRT as options in pts with good PS. This single institution retrospective review, evaluated the UC experience of the impact of G+nab-p+/- CRT in LAPC. Methods: From 05/01/09-09/01/11,105 newly registered pts were identifiedusing ICD code 157, 13pts met inclusion criteria: ECOG PS 0-2, histologically proven LAPC, without prior therapy that received G + nab-P, pre or post radiation as part of their treatment. G+nab-p was given as cycles of G=1,000mg/m2 and nab-P=100mg/m2 weekly x3 every 4 weeks with appropriate modifications. CT scans and CA19-9 levels were followed. PFS was estimated from the date of diagnosis to date of progression or death if this occurred first and OS was estimated from date of diagnosis until date of death or loss to follow up. Kaplan Meier survival estimates were obtained with 95% confidence interval (CI). Log rank test was used to compare the PFS according to categorical variables. Results: Median duration of follow up was estimated to be 14.4 months (M) range(R) (5.8-19). CA19-9 data was available for 12 pts, 2 had baseline <1 (R<1-12,861), CA19-9 decrease > 50% from baseline was seen in 9/10. Mean # of G+nab-P cycles administered was 3, R (1-10). 77% received G based CRT with only 1pt receiving this post op. 38% (5/13) underwent resection, 4 post CRT with R0 margins and -ve LN’s and 1 pre CRT with R0 margins but 1/13 LN’s +ve. 11 pts were evaluable for response by RECIST (4PR, 6SD, 1PD). Disease control rate 91%. PFS 92% (CI: 57- 99%) at 6 M and 65% (CI: 31-85%) at 12 M. OS was 85% (CI: 51-96%) at 6M and 77 %(CI: 44-92%) at 12M. At 6M, 100% PFS was observed in resected group, whereas 88% PFS in non-resected group (p=0.12). There was no significant difference in PFS according to gender (p=0.44) and T lesion (p=0.49). Grade III/IV toxicity was mainly hematologic and gastrointestinal. (4/7) 57% received further therapy upon progression. Conclusions: Compared to contemporary G- based trials, the UC experience of G+ nab-P with CRT appears to be associated with improved survival in LAPC and warrants further study.

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

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4116-4116 ◽  
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.

KRAS mutation status-stratified randomized phase II trial of GEMOX with and without cetuximab in advanced biliary tract cancer (ABTC): The TCOG T1210 trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4018-4018 ◽  
Author(s):  
Li-Tzong Chen ◽  
Jen-Shi Chen ◽  
Yee Chao ◽  
Chang-Sung Tsai ◽  
Yan-Shen Shan ◽  
...  
Keyword(s):  
Phase Ii ◽  
Kras Mutation ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Phase Iii ◽  
Mutation Status ◽  
Randomized Phase Ii ◽  
Ecog Ps ◽  
The Impact ◽  
Kras Mutation Status

4018 Background: Gemcitabine/platinum combination is considered as globally acceptable standard care in patients with ABTC. Two recently published randomized trials showed adding EGFR antagonist, either erlotinib or cetuximab, does not further improve the clinical outcomes of gemcitabine/oxaliplatin (GEMOX)-treated ABTC patients. However, the impact of KRAS mutation status on the results of both studies was not properly addressed. Methods: A prospective, multicenter randomized, phase II trial to evaluate the therapeutic efficacies of adding cetuximab to GEMOX in patients with ABTC, in which eligible patients were stratified by status of KRAS mutation and ECOG PS, and tumor location then randomized to receive either GEMOX (gemcitabine 800 mg/m2, fixed-rate infusion and oxaliplatin 85 mg/m2, i.v., Q 2 weeks) or GEMOX plus cetuximab (500 mg/m2, i.v., Q 2 weeks, C-GEMOX). The primary endpoint was overall response rate (ORR). As an exploratory trial, 120 (60 per arm) patients was estimated to detect a two-tailed 10% difference in ORR (20% in GEMOX and 30% in C-GEMOX) with a significant level of a=0.2 and b=0.5. Results: Between Nov 2010 and May 2012, a total of 122 patients were accrued. The demography was male: 47.5%, median age: 60 y/o, ECOG PS 0/1: 28.7%/71.3%, IHCC/EHCC/GBC: 71.3%/16.4%/12.3%, KRAS mutation: 36.1%, with locally advanced/metastatic diseases: 32.0%/68.0%, and prior surgical resection: 41.8%. On intent-to-treat analysis, the ORR and DCR in the C-GEMOX (N=62) and GEMOX (N-60) arms was 27.3% vs 15.0% (p=0.1223) and 82.2% vs 60.0% (p=0.0090), respectively (Fisher’s exact test); while the median PFS was 7.1 vs 4.0 months (p= 0.0069) and median OS was 10.3 vs 8.8 months (p=0.4057), respectively (log-rank test). Planned subgroup analysis showed the 43 patients with KRAS mutated tumors benefited more from cetuximab therapy, with a DCR of 78.3% vs 38.1% (p=0.0132), median PFS of 7.0 vs 1.9 months (p=0.0351) and median OS of 10.3 vs 6.6 months (p=0.6924). Conclusions: Adding cetuximab significant improves the DCR and PFS of GEMOX in ABTC patients, notably in subpopulation with KRAS mutated tumors. Larger-scale phase III trial is warranted. Clinical trial information: NCT01267344.

Quality of life and safety profile of pemetrexed-platinum doublet in Indian adult chemo-naive NSCLC patients.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19118-e19118
Author(s):  
Vikram Gota ◽  
Krunal Vasant Kavathiya ◽  
Damodaran S E ◽  
Amit Joshi ◽  
Vanita Noronha ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Locally Advanced ◽  
Global Health Status ◽  
Significant Difference ◽  
Nsclc Patients ◽  
The Impact ◽  
Platinum Doublet

e19118 Background: Pemetrexed in combination with cisplatin or carboplatin is commonly recommended for the first-line treatment of patients with locally advanced or metastatic NSCLC of adenocarcinoma histology. The present study explores the safety and the impact of this doublet on the quality of life in adult Indian NSCLC patients. Methods: Patients were enrolled from a single tertiary care cancer hospital in India. Patients were administered pemetrexed 500 mg/m2, cisplatin 75 mg/m2or carboplatin AUC 5 every 3 weekly. All patients received standard folate and Vitamin B12 supplementation. Premedication included dexamethasone, granisetron and ranitidine. Quality of Life (QoL) data was collected at baseline and at completion of 3 cycles using EORTC QLQ-C30 (version 3) and QLQ- LC13 questionnaires. Toxicity was graded using CTCAE v. 4.03. Results: Twenty seven patients were enrolled on the study since July 2012.Twenty received carboplatin and seven received cisplatin. Mean age of the participants was 54.7 years (SD=9.58) with stage (IV=25; III A/B=2) and ECOG performance status (0=1; 1=17; and 2=9). Pemetrexed–platinum doublet caused significant improvement in Global Health Status and dyspnea score at 3 cycles compared to baseline (Table). The treatment also caused marked improvement in the physical function, emotional function, cognitive function and insomnia scales, although not statistically significant (Table). No significant difference compared to baseline was observed for other parameters. Grade 3/4 toxicities include anemia (3), neutropenia (3), hyponatremia (6), vomiting), diarrhea, and dyspnea (1 each). Conclusions: Pemetrexed-platinum doublet was well tolerated and markedly improved the global health status and dyspnoea at the end of three cycles. A higher incidence of hyponatreemia was observed in our cohort that needs to be investigated further. [Table: see text]

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