A randomized phase II study of individualized stereotactic body radiation therapy (SBRT) versus transarterial chemoembolization (TACE) with DEBDOX beads as a bridge to transplant in hepatocellular carcinoma (HCC).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 223-223 ◽  
Author(s):  
Francis W. Nugent ◽  
Amir Qamar ◽  
Keith E. Stuart ◽  
Kari Galuski ◽  
Sebastian Flacke ◽  
...  
Keyword(s):  
Stereotactic Body Radiation Therapy ◽  
Locally Advanced ◽  
Bridge To Transplant ◽  
Class A ◽  
Randomized Phase Ii ◽  
Median Total Dose ◽  
Secondary Endpoints ◽  
Prescription Dose ◽  
Clinical Trial Information

223 Background: For HCC pts undergoing LT, local regional treatment as a "bridge" is standard to decrease tumor progression. The most common treatment is TACE, but the best bridging modality is unclear. Recently, SBRT has been shown to be both safe and effective when used in pts with locally advanced HCC. We prospectively compare SBRT to TACE as a bridge for HCC pts undergoing LT. Methods: 60 pts planned for accrual. From 9/2014-9/2016, 29 pts within Milan Criteria with C-P Class A/B cirrhosis were randomized to TACE vs. SBRT. TACE pts received 2 treatments one month apart utilizing DEBDOX beads (n = 15). TACE pts were hospitalized after each TACE. Pts receiving SBRT (n = 12) received a median total dose of 45Gy delivered over 5 fractions using fiducials. Mean liver dose, Veff, and NTCP were utilized to determine the prescription dose. Pts were assessed by imaging using mRECIST criteria at 2 months and every 3 months thereafter until LT or death. Toxicity and quality of life were assessed before treatment, during treatment, two weeks post-treatment, and then every three months using the PIQ-6 Pain Impact Questionnaire and the SF-36v2 Health Survey. Primary endpoint was time to retreatment of treated lesion(s). Secondary endpoints include toxicity, pathologic response, radiologic response, number of subsequent treatments, cost, and QOL. Results: A. Demographics/Toxicity. Conclusions: For HCC patients with C-P Class A/B liver cirrhosis, SBRT appears equally effective to TACE as a bridge to liver transplantation, may engender less toxicity, and eliminates hospitalizations. Clinical trial information: NCT02182687. [Table: see text][Table: see text]

A randomized phase II feasibility study of individualized stereotactic body radiation therapy (SBRT) versus transarterial chemoembolization (TACE) with DEBDOX beads as a bridge to transplant in hepatocellular carcinoma (HCC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4586-4586 ◽  
Author(s):  
Francis W. Nugent ◽  
Klaudia Hunter ◽  
Chris Molgaard ◽  
Amir Qamar ◽  
Krishna Gunturu ◽  
...  
Keyword(s):  
Stereotactic Body Radiation Therapy ◽  
Early Stage ◽  
Bridge To Transplant ◽  
Class A ◽  
Randomized Phase Ii ◽  
Median Total Dose ◽  
Secondary Endpoints ◽  
Prescription Dose ◽  
To Receive ◽  
Clinical Trial Information

4586 Background: For HCC pts undergoing LT, loco-regional treatment as a "bridge" is standard. The best bridging modality is unclear. SBRT is safe and effective when used in pts with advanced HCC. We prospectively compared SBRT to TACE as a bridge for HCC pts undergoing LT. Methods: From 9/2014-10/2019, 60 pts within Milan Criteria with CTP Class A/B8 cirrhosis were consented. 54 pts were randomized to TACE vs. SBRT. TACE pts (n =30) were scheduled to receive 2 treatments one month apart utilizing DEBDOX beads. TACE pts were hospitalized after each TACE. Pts receiving SBRT (n =24) received a median total dose of 45Gy delivered over 5 fractions using fiducials. Mean liver dose, Veff, and NTCP determined prescription dose. Pts were assessed by using mRECIST criteria at 2 months and every 3 months thereafter until LT or death. Toxicity and QOL were assessed before treatment, during treatment, two weeks post-treatment, and then every three months using the PIQ-6 Pain Impact Questionnaire and the SF-36v2 Health Survey. The 1° endpoint was time to recurrent or residual dz. Secondary endpoints were toxicity, pathologic response, radiologic response, number of subsequent treatments, cost, and QOL. 50 pts are evaluable for review. Results: See table. Conclusions: For early stage HCC patients with CTP Class A/B liver cirrhosis, SBRT appears as effective as TACE at controlling HCC prior to LT, may engender less toxicity, and eliminates the need for hospitalization. A larger multi-center trial is ongoing. Clinical trial information: NCT02182687. [Table: see text]

A randomized phase II study of individualized stereotactic body radiation therapy (SBRT) versus transarterial chemoembolization (TACE) as a bridge to transplant in hepatocellular carcinoma (HCC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15677-e15677 ◽  
Author(s):  
Francis Warren Nugent ◽  
Krishna Gunturu ◽  
Keith E. Stuart ◽  
Sebastian Flacke ◽  
Chris Molgaard ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Local Treatment ◽  
Milan Criteria ◽  
Bridge To Transplant ◽  
Class A ◽  
Randomized Phase Ii ◽  
Median Total Dose ◽  
Secondary Endpoints ◽  
Prescription Dose ◽  
Previously Treated

e15677 Background: For HCC pts undergoing LT, local treatment as a "bridge" is standard to decrease likelihood of tumor progression. The most common treatment is TACE, but the safest and most effective bridging modality is unclear. Recently, SBRT has been shown to be both safe and effective when used in pts with locally advanced HCC. We prospectively compare SBRT to TACE as a bridge for HCC pts undergoing LT. Methods: 60 pts are planned for accrual. Pts with C-P < 9 and HCC within Milan Criteria were randomized between two arms. TACE pts received 2 treatments one month apart using DEBDOX beads. TACE pts were hospitalized after each treatment. Pts randomized to SBRT, after fiducial placement, received a median total dose of 45 Gy delivered over 5 fractions. Mean liver dose, Veff, and NTCP were utilized to determine the prescription dose. Pts were assessed by imaging using mRECIST criteria at 2 months and every 3 months thereafter until LT or death. Toxicity and quality of life (QOL) were assessed before treatment, during treatment, 2 weeks post-treatment, and then every 3 months using the PIQ-6 Pain Impact Questionnaire and the SF-36v2 Health Survey. Primary endpoint was need for retreatment of the previously treated lesion(s). Secondary endpoints include toxicity, pathologic response, radiologic response, QOL, and cost. Results: From 9/2014-1/17, 33 pts within Milan Criteria with C-P Class A/B cirrhosis were randomized to TACE (n = 18) vs. SBRT (15). Data on evaluable pts is summarized in the table below. Conclusions: For HCC patients with C-P Class A/B liver cirrhosis, SBRT appears at least equally effective as TACE as a bridge to liver transplantation. SBRT may engender less toxicity, better maintain QOL, and eliminate the need for hospitalization. An update along with a full cost analysis will be presented in June. Clinical trial information: nct02182687. [Table: see text]

Randomized phase II study of gemcitabine-oxaliplatin or gemcitabine-cisplatin in chemonaive patients with advanced non-small cell lung cancer (NSCLC)-CLEO 05

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7097-7097 ◽  
Author(s):  
T. Le Chevalier ◽  
S. Thezenas ◽  
J. Breton ◽  
J. Pujol ◽  
B. Coudert ◽  
...  
Keyword(s):  
Objective Response ◽  
Stage Iv ◽  
Patient Characteristics ◽  
Median Number ◽  
Stage Iiib ◽  
Randomized Phase Ii ◽  
Secondary Endpoints ◽  
Number Of Cycles ◽  
To Receive

7097 Background: Gemcitabine-cisplatin is one of the reference doublets used in NSCLC. Oxaliplatin is a platin analog which offers a promising efficacy/tolerance profile in NSCLC. The combination of gemcitabine and oxaliplatin has been proven feasible and active in solid tumors. Methods: Patients with chemonaive, measurable, PS 0 or 1, stage IIIB/ IV NSCLC were randomized to receive either gemcitabine 1,250 mg/m2 day 1 & 8 plus oxaliplatin 130 mg/m2 day 1 (GEMOX) or gemcitabine 1,250 mg/m2 day 1 & 8 plus cisplatin 80 mg/m2day 1 (GEMCIS). Cycles were given every 3 weeks. The primary endpoint of the study was the response rate according to the RECIST criteria. Secondary endpoints included tolerance, survival and quality of life. Results: Between October 2003 and December 2004, 130 patients (66 in GEMOX and 64 in GEMCIS) were accrued at 12 centres. Baseline patient characteristics were similar in the 2 groups. Mean age was 61. There were 96 males and 34 females; 27% of patients were PS 0 and 73% were PS 1; 15% had stage IIIB and 85% had stage IV. Median number of cycles was 5 in each group. Objective response rates were 36% in GEMOX (CI 95%: 25%-50%) and 39% in GEMCIS (CI 95%: 28%-54%) respectively. Time to progression was 173 days in the GEMOX group and 163 days in the GEMCIS group. Median survival was 10.8 months in the GEMOX group and 10.4 months in the GEMCIS group. Grade III/IV neutropenia was observed in 38% of patients after GEMOX and 41% after GEMCIS; thrombocytopenia was observed in 40% and 33% of cases respectively. Grade 2+ neurotoxicity was more frequent after GEMOX (18% vs 3%). Conclusions: GEMOX has an activity comparable to GEMCIS and may be an alternative for those patients with advanced NSCLC who have a contra-indication to cisplatin. [Table: see text]

Multicenter randomized phase II study of chemoradiation (CRT) followed by surgery (S) and chemotherapy (CT) versus induction CT followed by CRT and S in high-risk rectal cancer: GCR-3 final efficacy and safety results

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4103-4103
Author(s):  
C. Fernandez-Martos ◽  
J. Aparicio ◽  
A. Salud ◽  
V. Alonso ◽  
B. Massuti ◽  
...  
Keyword(s):  
High Risk ◽  
Locally Advanced ◽  
Dose Intensity ◽  
Treatment Compliance ◽  
Complete Response ◽  
R0 Resection ◽  
Randomized Phase Ii ◽  
Secondary Endpoints ◽  
Therapeutic Sequence ◽  
Intent To Treat

4103 Background: In locally advanced RC the optimal therapeutic sequence remains an important clinical question. Induction CT prior to CRT and S may be associated with better efficacy and compliance. Methods: Eligible pts had medium or distal high risk RC defined by MRI and/or US: Tumors within 2mm of mesorectal fascia, distal T3 at/below levators, resectable T4 and T3N+. Pts, stratified by center, were randomized assigned to receive either Arm A : capecitabine (Cap) 825 mg/m2 BID 5 d/w, oxaliplatin (Ox) 50 mg/m2 IV weekly x 5 and concomitant RT: 50.4 Gy in 28 fractions. S was planned 5–6 w after CRT. Post-op four cycles of Cap 1,000 mg/m2 bid days 1 to 14; Ox 130 mg/m2 day 1 or Arm B: Induction CapOx followed by CRT and S. Two parallel, Simon 2-stage designs: α=0.05 β=0.1; 24 evaluable pts/arm 1st stage and 54 pts/arm for 2nd stage. Primary endpoint: pathological complete response (pCR). Secondary endpoints included toxicity and treatment compliance. Results: 108 Pts were randomly assigned (arm A/B, 52/56), and 103 were assessable (49/54) from 14 sites. Median age 62/60 years, Male 65/70%. During treatment period 6 pts died A/B: 2 vascular, 1 suicide/ 3 post-op. Pts with any grade ¾ toxicity during CRT were arm A/B: 29% (14/49) and 23% (12/53). Any grade ¾ toxicity during adjuvant/induction CT were 51% (19/37) and 17% (9/54); χ2,p= 0.0004. On an intent-to-treat basis the pCR for Arm A/B was achieved in seven (13.5%; 95% CI, 5.6%-25.8%) and eight (14.3%; 95% CI, 6.4%-26.2%). R0 resections were achieved in 92% (45/49) and 88% (48/54). 51% (25/49) and 93% (50/54) received all four cycles of adjuvant/induction CT (χ2;p<0.0001). Relative Median Dose intensity of adjuvant /induction CT was 0.74/0.96 (Wilcoxon; p<0.0001) for Cap and 0.75/1.0 (Wilcoxon; p<0.0001) for Ox. Conclusions: Induction CT prior to CRT has more favorable compliance and toxicity profiles. Furthermore, there is no compromise in pCR and R0 resection rates. Larger trials evaluating this strategy are justified. [Table: see text]

Phase III randomized trial of definitive chemoradiotherapy (CRT) with FOLFOX or cisplatin and fluorouracil in esophageal cancer (EC): Final results of the PRODIGE 5/ACCORD 17 trial.

2012 ◽  
Vol 30 (18_suppl) ◽  
pp. LBA4003-LBA4003 ◽  
Author(s):  
Thierry Conroy ◽  
Marie-Pierre Galais ◽  
Jean Luc Raoul ◽  
Olivier Bouche ◽  
Sophie Gourgou-Bourgade ◽  
...  
Keyword(s):  
Squamous Cell ◽  
Treatment Options ◽  
Complete Response ◽  
Phase Iii ◽  
Eligibility Criteria ◽  
Randomized Phase Ii ◽  
Secondary Endpoints ◽  
Grade 3 ◽  
Ecog Ps

LBA4003 Background: CRT is one of the best treatment options for localized EC. As new combinations are required to improve safety and survival, we launched a randomized phase II study to assess the complete response (CR) rate of CRT with FOLFOX versus 5FU/cisplatin in 97 pts with localized EC (Conroy 2010). The trial having met its objectives, it has been pursued as a phase III trial. Stratified randomization was performed centrally in a 1:1 ratio according to histological type, pretreatment weight loss in the prior 6 months (<10% vs ≥10%), ECOG PS (0 vs 1 vs 2), and center. Methods: Pts with technically unresectable cancer or those with surgical contraindications or who refused to undergo surgery were eligible. Eligibility criteria also included age >18 years (y), PS ≤ 2, previously untreated adenocarcinoma or squamous cell EC (any T, N0 or N1, M0 or M1a). The radiation dose was 50 Gy (2Gy/fr) 5 d/wk for 5 wks in both arms. In Arm A, pts received 6 bimonthly cycles (cy): oxaliplatin 85 mg/m2 d1 and leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 bolus d1 then 1,600 mg/m2 46h continuous infusion (ci) ; the first 3 cy were delivered during RT, the 3 other after. In Arm B, pts received 4 cy: cisplatin 75 mg/m2 d1 followed by 5FU 1,000 mg/m2/d ci d1-4, the first 2 cy during RT and 2 other after. The primary endpoint was PFS. Main secondary endpoints were OS, grade 3-4 toxicities, and quality of life. A total of 266 pts would provide 90% power to detect a 20% 3y-PFS difference (α=0.05). Results: 267 pts were enrolled between 10/2004 and 08/2011. Treatment cohorts were well balanced: male 81%; median age 61 y; PS 0 53%, squamous cell 85.8%, stage III 52%, IVA 6.0% and IVB 3.0%. Full treatment was delivered to 67.9% and 72.2% of pts in arms A/B, respectively. 7 toxic deaths occurred in each arm. Grade 3/4 toxicities per pt (%) in arms A/B were neutropenia 30.6/31.3, febrile neutropenia 5.3/7.0, anemia 5.4/11.0, asthenia 17.6/10.2, respectively. The median FU time was 25.3 mos. 3y-PFS was 18.2/17.4 % (HR=1.07; 95%CI =0.80-1.43) and median OS was 20.2 /17.5 m (HR=1.06; 95%CI =0.77-1.46). Conclusions: CRT with FOLFOX does not improve PFS compared to cisplatin and 5-FU and has similar toxicities.

Impact of stereotactic body radiation therapy on patient-reported quality of life in patients with unresectable or recurrent pancreatic cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 413-413
Author(s):  
Lauren M. Rosati ◽  
Zhi Cheng ◽  
Scott P. Robertson ◽  
Megan N. Kummerlowe ◽  
Amy Hacker-Prietz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Stereotactic Body Radiation Therapy ◽  
Locally Advanced ◽  
Future Health ◽  
Stereotactic Body Radiation ◽  
Patient Reported ◽  
The Impact

413 Background: The impact of fractionated stereotactic body radiation therapy (SBRT) on patient-reported quality of life (QOL) and physician-reported toxicity in patients with recurrent or locally advanced pancreatic cancer (PCA) was prospectively evaluated. Methods: Forty-two PCA patients were treated with 25-33 Gy using SBRT in 5 fractions on a single-institution study. Both patient- and physician-reported outcomes were evaluated prior to SBRT and 4-6 weeks post-SBRT. Eight outcomes were consistently evaluated among both groups—performance status, fatigue, pain, anorexia, nausea, vomiting, constipation, and diarrhea. Patient-reported QOL metrics were assessed using a 4-point Likert scale on the EORTC QLQ-C30 and QLQ-PAN26, while physician-reported toxicities were graded using the NCI CTCAE version 4.0. Comparisons between those with paired patient- and physician-reported outcomes collected prior to and 4-6 weeks after SBRT were made using the Wilcoxon signed-rank test. Results: Of the 42 patients currently enrolled onto the study, 29 had both patient- and physician-reported outcomes collected prior to and 4-6 weeks after SBRT. Fifty-five percent were female and 83% were Caucasian. The median age at diagnosis was 65.6 years (range, 40.8-86.6). There was no significant impairment of any of the 8 physician-reported toxicities, nor were significant changes observed in patient-reported overall health (p = 0.66) or QOL (p = 0.18) scores following SBRT. Patients felt less worried about their future health (mean change [mD] = -0.45, p = 0.02), and an improvement in feeling less attractive as a result of disease and treatment reached borderline significance (mD= 0.31, p = 0.09). However, patients felt limited in planning activities in advance (mD= 0.45, p = 0.02) and were more constipated (mD= 0.38, p = 0.01) 4-6 weeks post-SBRT. Conclusions: Although the numbers are small, patients with unresectable or locally recurrent PCA do not appear to suffer any detriment of overall health or QOL after receiving a five-day course of SBRT. Moreover, this regimen may lead to a more optimistic point of view on future health and/or level of physical attraction. Clinical trial information: NCT01781728.

Halo 110-101: Early safety results of pegvorhyaluronidase alfa (PEGPH20; PVHA) + cisplatin (C) + gemcitabine (G) ± atezolizumab (ATZ) in patients (pts) with locally advanced or metastatic cholangiocarcinoma (CCA) and gallbladder cancer (GBC).

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 408-408
Author(s):  
Do-Youn Oh ◽  
Mann Muhsin ◽  
Andrea J. Bullock ◽  
Ghassan K. Abou-Alfa ◽  
Rachna T. Shroff ◽  
...  
Keyword(s):  
Immune Cell ◽  
Locally Advanced ◽  
Standard Of Care ◽  
Primary Endpoints ◽  
Secondary Endpoints ◽  
Phase Clinical Trial ◽  
The Mean ◽  
The Individual ◽  
Dose Limiting Toxicity ◽  
Clinical Trial Information

408 Background: Standard of care for CCA/GBC is C-G therapy. MAbs (ATZ, pembrolizumab) targeting PD-L1 show promise in treating CCA/GBC. Hyaluronan (HA), which may impede drug and immune cell access, is high (67%) in CCA/GBC tumors. PEGPH20 enzymatically degrades HA. HALO 110-101 (NCT03267940) evaluates safety and activity of PEG-C-G-ATZ or PEG-C-G versus C-G in CCA/GBC pts. Methods: This study comprises two parts. In Run-In (RI) six pts were enrolled in PEG-C-G arm, then six pts in PEG-C-G-ATZ arm. Eight additional pts may be enrolled for tolerability. In Expansion (EX), up to 50 pts will be enrolled for efficacy. Treatment (Tx) cycle is 21 days (d). PEGPH20 dose is 3 μg/kg on d1, eight and 15 and ATZ dose is 1200 mg (one–three hours after PEGPH20) on d1 (PEG-C-G-ATZ only). C-G is dosed at 25 mg/m2 C and 1000 mg/m2 G on d2 and nine. In C-G arm (EX only), C-G is dosed on d1 and 8. Primary endpoints are ORR (RECIST v1.1), AEs (NCI CTCAE v4.03), laboratory/safety (RI only); secondary endpoints are PK; DOR, DCR, PFS; OS, OS by PD-L1 expression; ORR and DOR (imRECIST). Results: Eighteen pts have been enrolled (nine in each arm). The mean (SD) age is 57 (12.2) yrs in PEG-C-G and 69 (8.8) yrs in PEG-C-G-ATZ. 56% were men. All pts experienced ≥ 1 AE. The most common AEs are nausea, fatigue (50% each); decreased appetite (44%); anemia, constipation (39% each); thrombocytopenia, oedema peripheral, AST increased, myalgia (33% each). To date, there has been one dose-limiting toxicity (febrile neutropenia) in the PEG-C-G arm. There have been no deaths due to AEs. Conclusions: The overall safety profile of PEGPH20 + C + G ± ATZ is acceptable and consistent with safety observed for the individual components. There were no DLTs resulting in a dose reduction of PEGPH20, which is being dosed at 3 μg/kg in the EX phase. Clinical trial information: NCT03267940. [Table: see text]

TRANSFORMER: Bipolar androgen therapy (BAT) versus enzalutamide (E) for castration-resistant metastatic prostate cancer (mCRPC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5517-5517
Author(s):  
Samuel R. Denmeade ◽  
Hao Wang ◽  
Harry Cao ◽  
Wei Fu ◽  
Ting Wang ◽  
...  
Keyword(s):  
Randomized Study ◽  
Phase 2 Trial ◽  
Castration Resistant ◽  
Psa Response ◽  
Secondary Endpoints ◽  
Psa Progression ◽  
Low Testosterone ◽  
Intent To Treat ◽  
Clinical Trial Information

5517 Background: Rapid cycling between high and low testosterone (T) (i.e BAT) produces tumor response in mCRPC, and may overcome resistance to newer AR therapies. Here we report a randomized study comparing BAT to E in men with mCRPC progressing on abiraterone (A). Methods: In this phase 2 trial, men received either T cypionate 400mg IM (BAT) once every 28 days or daily oral E 160mg. Primary endpoint was clinical/radiographic PFS; crossover was permitted at progression. Secondary endpoints were OS, PSA progression to primary and crossover therapy, PSA and objective responses (OR), time to PSA progression from randomization through crossover (PFS2), quality of life (QoL), and AEs. Results: 195 men were randomized (94 to BAT, 101 to E). Results are presented in table. Although diametrically opposed therapies, median PFS and PSA response in the intent-to-treat (ITT) population was not significantly different between BAT and E. OR and OS favored BAT. For those who received BAT and then crossed over to E the PSA50 response was 77.8% and time to PSA progression was 10.9 mo compared to 25.3% and 3.8 mo for those receiving E immediately after A. The sequence of treatment had a significant effect on median PSF2 which was 28.2 mo for men receiving BAT→E vs. 19.6 m for E→BAT. For men who crossed over from BAT to E, OS was 37.3 mo vs. 28.6 months for those receiving E without crossover. AEs were primarily grade 1-2 in the BAT arm and included fatigue, generalized pain, and lower extremity edema. BAT improved QoL (fatigue, physical functioning, sexual function) vs. E. Conclusions: BAT could be safely administered to asymptomatic men with mCRPC. BAT produced a comparable PFS to E in A-refractory mCRPC pts. However, PSA50 and OR after crossover, as well as PFS2, were significantly improved in men who received BAT→E versus E→BAT. OS in men receiving BAT→E was 37.3 mo, exceeding historical expectations. These results support the hypothesis that treatment with BAT is safe, has efficacy and can restore sensitivity to antiandrogens. Clinical trial information: NCT02286921 . [Table: see text]

PARTNER: A randomized phase II study of docetaxel/cisplatin (doc/cis) chemotherapy with or without panitumumab (pmab) as first-line treatment (tx) for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6029-6029 ◽  
Author(s):  
Lori J. Wirth ◽  
Shaker R. Dakhil ◽  
Gabriela Kornek ◽  
Rita Axelrod ◽  
Douglas Adkins ◽  
...  
Keyword(s):  
Phase Ii ◽  
Objective Response ◽  
Progression Free Survival ◽  
Free Survival ◽  
Randomized Phase Ii ◽  
Hpv Status ◽  
Secondary Endpoints ◽  
Baseline Characteristics ◽  
Grade 3 ◽  
Clinical Trial Information

6029 Background: PARTNER was a multicenter, randomized phase II estimation study evaluating 1stEline tx of R/M SCCHN with doc/cis ± pmab. Methods: Patients (pts) were randomized 1:1 to doc/cis with pmab (Arm 1) or doc/cis alone (Arm 2). Arm 1 received 9 mg/kg pmab on day 1 of each 21-day cycle, and all pts received 1stEline doc/cis both at 75 mg/m2 on day 1 for up to 6 cycles. In Arm 1, pts could receive pmab monotherapy upon completion of 6 cycles of doc/cis until disease progression (PD). In Arm 2, pts could receive pmab as 2ndEline monotherapy upon PD. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), objective response rate (ORR), and safety. HPV status was determined using p16 INK IHC. No formal hypothesis was tested. Results: Baseline characteristics were balanced between arms. Of 103 pts, HPV status was evaluable in 66 (64%); 29% were HPV positive. Efficacy results are shown (Table). Worst grade 3/4 adverse events (AEs) were 73% in Arm 1 vs 56% in Arm 2. Conclusions: Median PFS was increased in both arms over historical doublet cytotoxic chemotherapy. PFS and ORR were higher in the pmab arm in the overall population, in the HPV positive (n=19) group, and in the HPV negative (n=47) group. There was an increase in grade 3/4 AEs with this regimen. The crossover design, with 57% of Arm 2 pts receiving pmab as 2ndEline monotherapy, confounds interpretation of OS. Clinical trial information: NCT00454779. [Table: see text]

Stereotactic body radiation therapy and patient-reported quality of life prospectively evaluated in patients with unresectable or recurrent pancreatic cancer.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 92-92
Author(s):  
Lauren M. Rosati ◽  
Zhi Cheng ◽  
Scott P. Robertson ◽  
Megan N. Kummerlowe ◽  
Amy Hacker-Prietz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pancreatic Cancer ◽  
Radiation Therapy ◽  
Stereotactic Body Radiation Therapy ◽  
Locally Advanced ◽  
Future Health ◽  
Stereotactic Body Radiation ◽  
Patient Reported ◽  
The Impact

92 Background: The impact of fractionated stereotactic body radiation therapy (SBRT) on patient-reported quality of life (QOL) and physician-reported toxicity in patients with recurrent or locally advanced pancreatic cancer (PCA) was prospectively evaluated. Methods: Forty-two PCA patients were treated with 25-33 Gy using SBRT in 5 fractions on a single-institution study. Both patient- and physician-reported outcomes were evaluated prior to SBRT and 4-6 weeks post-SBRT. Eight outcomes were consistently evaluated among both groups—performance status, fatigue, pain, anorexia, nausea, vomiting, constipation, and diarrhea. Patient-reported QOL metrics were assessed using a 4-point Likert scale on the EORTC QLQ-C30 and QLQ-PAN26, while physician-reported toxicities were graded using the NCI CTCAE version 4.0. Comparisons between those with paired patient- and physician-reported outcomes collected prior to and 4-6 weeks after SBRT were made using the Wilcoxon signed-rank test. Results: Of the 42 patients currently enrolled onto the study, 29 had both patient- and physician-reported outcomes collected prior to and 4-6 weeks after SBRT. Fifty-five percent were female and 83% were Caucasian. The median age at diagnosis was 65.6 years (range, 40.8-86.6). There was no significant impairment of any of the 8 physician-reported toxicities, nor were significant changes observed in patient-reported overall health (p = 0.66) or QOL (p = 0.18) scores following SBRT. Patients felt less worried about their future health (mean change [mD] = -0.45, p = 0.02), and an improvement in feeling less attractive as a result of disease and treatment reached borderline significance (mD= 0.31, p = 0.09). However, patients felt limited in planning activities in advance (mD= 0.45, p = 0.02) and were more constipated (mD= 0.38, p = 0.01) 4-6 weeks post-SBRT. Conclusions: Although the numbers are small, patients with unresectable or locally recurrent PCA do not appear to suffer any detriment of overall health or QOL after receiving a five-day course of SBRT. Moreover, this regimen may lead to a more optimistic point of view on future health and/or level of physical attraction. Clinical trial information: NCT01781728.

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