Exploration of patients with gastric cancer who benefit from apatinib: An updated real-world study.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 161-161 ◽  
Author(s):  
Guo-ping Sun ◽  
Dongliang Li ◽  
Zhongliang Ning ◽  
Yifu He ◽  
Fenglin Zhang ◽  
...  
Keyword(s):  
Real World ◽  
Combined Chemotherapy ◽  
Line Treatment ◽  
Open Label ◽  
Hand Foot Syndrome ◽  
Third Line ◽  
Grade 3 ◽  
Ecog Ps ◽  
Clinical Trial Information

161 Background: A real-world study to observe the efficacy and safety of apatinib treatment in clinical practice, and explored patients (pts) who could benefit from apatinib. Methods: This is an open-label, prospective, observational study, pts (age ≥ 18 yrs) with pathologically or histologically diagnosed GC who were given apatinib treatment met the inclusion criteria. Results: From September 1, 2017 to September 1, 2018. 954 pts were enrolled. 679 pts received palliative treatment were included in the analysis. 499 (73.6%) were males. The age of the pts was (63.1 ± 10.8) yrs. Pts with ECOG PS 0/1 accounted for 78.1%. Pts received first-line treatment, second-line treatment, third-line treatment or above , respectively were 42.2%, 30.5%, 27.3%. 509 (75.1%) pts were treated with apatinib at dose of 500 mg. There were 375 pts available for efficiency evaluation. Among them, 1 achieved CR, 35 achieved PR, 198 had SD, and 57 had PD, resulting in an ORR of 11.9% and a DCR of 77.4%. The mPFS is 4.2 m (95% CI: 3.5-4.8), OS data was still in follow-up. This study showed its efficacy for pts with monotherapy compared with combined chemotherapy (3.3 m vs. 5.0 m, P = 0.003). The mPFS for patients with hypertension were longer than without hypertension (7.1m vs. 3.7m, P = 0.038). And pts also had longer mPFS with good ECOG PS (0-1) compared to those with poor ECOG PS (2-4) (4.7 m vs. 2.9 m, P = 0.003). The incidence of AEs was 402 (88.2%) and the grade 3/4 treatment-related AEs was 14.7%. The most common treatment-related AEs were debilitation (31.2%), hand-foot syndrome (27.5%), hypertension (25.3%), anorexia (11.5%), diarrhea (10.3%), albumin decreased (38.5%), uric acid elevated (31.6%), and total bilirubin increased (29.1%). Conclusions: In the real world, apatinib is confirmed to be effective and safe for GC pts. Factors associated with better prognosis were apatinib combined chemotherapy, ECOG PS 0/1 and occurrence of hypertension. Further analysis is needed to identify pts who benefit from apatinib treatment. Preliminary results of the study were released in ESMO 2018 Congress (683P). Clinical trial information: NCT 03333967.

Phase II trial of radiation therapy/temozolomide followed by temozolomide/sorafenib in the first-line treatment of glioblastoma multiforme (GBM)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 2018-2018
Author(s):  
R. E. Lamar ◽  
D. R. Spigel ◽  
H. A. Burris ◽  
T. M. Markus ◽  
M. Kuzur ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Line Treatment ◽  
First Line ◽  
Complete Surgical Resection ◽  
Adequate Organ Function ◽  
Grade 3 ◽  
X 24 ◽  
Ecog Ps ◽  
First Line Treatment

2018 Background: Anti-angiogenesis agents have recently shown activity in the treatment of patients (pts) with GBM. We added sorafenib, a multi-targeted TKI, to the standard first-line treatment of patients with GBM. Methods: Pts with histologically documented GBM were eligible at diagnosis or after resection. Additional entry criteria: ECOG PS 0 or 1; adequate organ function; ability to swallow pills; standard exclusions for antiangiogenesis agents. All pts initially received radiation therapy (total 60 Gy, 2 Gy by single daily fractions) plus temozolomide (75mg/m2 po daily). Four weeks after completion of radiation therapy, pts received temozolomide (150mg/m2 po days 1–5, repeated every 21 days for 6 cycles) plus sorafenib (400mg po bid daily x 24 weeks). Pts were evaluated every 8 weeks during temozolomide/sorafenib therapy, and every 3 months after therapy ended, until tumor progression. Median PFS was the primary endpoint. Results: Between April 2007 and July 2008, 45 pts were enrolled. The median age was 54 years; 30 pts (67%) had previous partial or complete surgical resection. 39 pts (87%) completed concurrent RT/temozolomide therapy, while 6 pts were removed from treatment (PD 4, toxicity 1, intercurrent event 1). 39 pts began treatment with temozolomide/sorafenib; 3 have completed all planned treatment, 8 remain on treatment, and 28 stopped treatment early (PD 22, toxicity 2, intercurrent event 1, pt decision 3). Best responses are as follows: CR, 1 pt (2%); PR, 5 pts (11%); stable disease, 22 pts (49%); progressive disease, 14 pts (31%). After a median follow-up of 9 months, median PFS for all pts was 6 months (95% confidence intervals, 2.7–7.8 months). Median PFS for pts who received at least 1 dose of sorafenib is also 6 months. The median overall survival is 16 months (95% CI, 7.2-NR months). Grade 3/4 toxicity during temozolomide/sorafenib was uncommon; 7 pts (16%) required dose reductions of sorafenib during their treatment course. Conclusions: The addition of sorafenib to standard treatment with RT/temozolomide is feasible and well tolerated by most pts. Preliminary efficacy is similar to standard therapy; updated results will be presented. [Table: see text]

Efficacy and safety of the anti-PD-1 monoclonal antibody MK-3475 in 411 patients (pts) with melanoma (MEL).

2014 ◽  
Vol 32 (18_suppl) ◽  
pp. LBA9000-LBA9000 ◽  
Author(s):  
Antoni Ribas ◽  
F. Stephen Hodi ◽  
Richard Kefford ◽  
Omid Hamid ◽  
Adil Daud ◽  
...  
Keyword(s):  
Pooled Analysis ◽  
Efficacy And Safety ◽  
Prior Therapy ◽  
Recist 1.1 ◽  
Appropriate Treatment ◽  
Related Response ◽  
Grade 3 ◽  
Ecog Ps ◽  
Clinical Trial Information

LBA9000^ Background: The humanized monoclonal IgG4 anti-PD-1 antibody MK-3475 has demonstrated durable antitumor activity in MEL and NSCLC. We evaluated MK-3475 efficacy and safety in a pooled analysis of 411 MEL pts. Methods: A nonrandomized cohort of ipilimumab-naive (IPI-N) and IPI-treated (IPI-T) pts treated with MK-3475 10 mg/kg Q2W, 10 mg/kg Q3W, or 2 mg/kg Q3W and randomized cohorts of IPI-N and IPI-T pts treated with 2 Q3W or 10 Q3W were included. Response was assessed every 12 wk by RECIST 1.1 by independent central review and by immune-related response criteria (irRC) by investigator. Results: 162 pts were treated at 2 Q3W, 192 at 10 Q3W, and 57 at 10 Q2W. 190 pts were IPI-N and 221 were IPI-T. As of the 10/18/2013 cutoff, all pts had ≥6 mo follow-up and >75% had ≥9 mo follow-up. Among the 365 pts with measurable disease at baseline, ORR by RECIST was 40% (95% CI 32%-48%) in IPI-N and 28% (95% CI 22%-35%) in IPI-T pts. Responses were durable (88% ongoing at analysis). Median PFS by RECIST was 24 wk in IPI-N and 23 wk in IPI-T pts. Median OS was not reached, with 1-y OS of 71% in all pts. Benefit was observed by both RECIST and irRC at all doses and schedules in IPI-N and IPI-T pts (Table). MK-3475 demonstrated activity in all major subgroups irrespective of ECOG PS, LDH levels, BRAFmutation, M stage, and number and type of prior therapy. Overall, 12% of pts experienced drug-related grade 3/4 AEs and 4% discontinued due to a drug-related AE. There were no drug-related deaths. Conclusions: MK-3475 showed durable responses and a manageable safety profile across dose and schedules in IPI-N and IPI-T MEL pts. The observed efficacy and safety suggest MK-3475 may be an appropriate treatment for all pts with MEL. Clinical trial information: NCT01295827. [Table: see text]

A real-world clinical study of camrelizumab in the treatment of esophageal cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16008-e16008
Author(s):  
Guoping Sun ◽  
Dong Qian ◽  
Dong Zhao ◽  
Hui Liang ◽  
Huaidong Cheng ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Adverse Event ◽  
Real World ◽  
Adverse Event Rate ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
Open Label ◽  
Multicenter Observational Study ◽  
History Of ◽  
Ecog Ps

e16008 Background: Camrelizumab, a fully humanized monoclonal antibody against PD-1, has been approved in the treatment of advanced esophageal squamous carcinoma in China. The purpose of this study was to observe the efficacy and safety of Camrelizumab in the treatment of esophageal cancer in the real world. Methods: This is an open-label, prospective, multicenter, observational study. Eligible patients (pts) who received Camrelizumab had esophageal cancer; age≥18, ECOG PS of 0-2; and measurable disease. Results: As of November 30, 2020, a total of 229 patients were enrolled, of which 192 were male (83.8%). The ECOG PS score was 0 in 48 cases (21.0%), 1 in 149 cases (65.0%), and 2 in 32 cases (14.0%). Among the 134 patients of stage IV patients (58.5%), 174 patients had metastases (76.0%), and 99% of patients did not undergo PD-L1 testing. A history of radiotherapy accounted for 57.6%, and a history of surgery on the primary lesion accounted for 42%. Camrelizumab accounted for 26.2% of the first-line treatment, 33.6% of the second-line treatment, and 35.4% of the third-line and above. Camrelizumab combined with chemotherapy accounted for 40%, combined with anti-angiogenesis therapy accounted for 38.0%, combined with anti-angiogenesis + chemotherapy accounted for 9.0%, and combined radiotherapy accounted for 6.2%. Among 145 patients with evaluable efficacy, 5 cases of CR, 14 cases of PR, 97 cases of SD, and 29 cases of PD. The ORR reached 13.1% and the DCR reached 80.0%. The overall adverse event rate was 42.8%, the major adverse event RCCEP rate was 11.7%, pneumonia was 8.3%, and fatigue was 4.1%. Adverse events greater than or equal to grade 3 included 1 case of RCCEP, 3 cases of bleeding, 1 case of diarrhea, and 1 case of fever. Conclusions: In this real-world study of esophageal cancer, most of the patients enrolled were patients with poor PS score and late stage, but the efficacy and safety of Camrelizumab in patients with advanced esophageal cancer were still confirmed. The dominant population and combination therapy are still under study. Clinical trial information: ChiCTR1900027275.

Capecitabine (X) compared to X + erlotinib (E) as first-line treatment in patients (pts) with metastatic colorectal cancer (MCRC): Interim efficacy results from a randomized phase II study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 14560-14560 ◽  
Author(s):  
M. Vincent ◽  
I. Kerr ◽  
B. Dingle ◽  
M. J. MacKenzie ◽  
M. Sanatani
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Growth Factor Receptor ◽  
First Line ◽  
Open Label ◽  
Dry Eyes ◽  
Open Label Phase ◽  
Grade 3 ◽  
Ecog Ps

14560 Background: The oral fluoropyrimidine X (Xeloda®) has efficacy, safety and convenience benefits vs. 5-FU/LV in adjuvant / first-line CRC. E (Tarceva®) inhibits epidermal growth factor receptor (EGFR), which predicts poor prognosis. A randomized open-label phase II study was performed to establish activity of X alone vs. X + E (XE) in first-line. Methods: Pts (ECOG PS 0–2 and/or elevated LDH) with MCRC not eligible for immediate surgical metastatectomy and unwilling/unable to undergo combination chemotherapy were randomized to X (1000mg/m2/d bid d1–14 q3w) or XE (X 1000mg/m2/d bid d1–14 q3w + E 150mg/d). A third arm (E alone) was included but dropped after 13 pts, following safety committee review of progressions at first CT scan. Primary endpoint: time to progression (TTP). Results: 59 pts (median age 65y, range 46–84; 44 M, 15 F) have been accrued (X=21; XE=25; E=13). Mean time on study: 3.8 months (range 0.2–12). 9 pts are on active treatment, 21 pts on follow-up and 29 pts have died. Interim efficacy results are available for 50 pts (X n=15; XE n=22, E n=13). There were no significant differences in response rate, median TTP (4.9 vs. 9.2 months) and median overall survival (18.2 vs. 15.1 months) for X vs. XE. Grade 3 adverse events (AEs) with X were diarrhea, nausea, hand-foot syndrome (HFS), angina, dyspnea (all 5%). Corresponding rates of grade 3 AEs with XE were diarrhea (20%), fatigue (16%), stomatitis (12%), HFS (8%), vomiting (8%), dehydration (8%), thrombosis, weight loss, decreased appetite, dry eyes, headache, anxiety, abdominal pain, anorexia, hyponatremia (all 4%). The only grade 4 AEs were skin rash (4%) and subjective weakness (4%) - both XE. Conclusions: Interim results indicate that XE is at least as effective as X alone in first-line MCRC. Recruitment is continuing and further follow-up may help fully determine the potential benefits of adding E to X. [Table: see text] No significant financial relationships to disclose.

Clinical experience with sunitinib (SU) in patients over age 65 with metastatic gastrointestinal stromal tumors (GIST): A retrospective study from the French Sarcoma Group (FSG).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 10546-10546 ◽  
Author(s):  
Florence Duffaud ◽  
Isabelle Ray-Coquard ◽  
Frederic Marchal ◽  
Loic Chaigneau ◽  
Olivier Bouche ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Positive Impact ◽  
Univariate Analysis ◽  
First Line ◽  
Hand Foot Syndrome ◽  
Specific Outcome ◽  
Grade 3 ◽  
Ecog Ps ◽  
Dose Reductions

10546 Background: Elderly GIST patients (pts) represent a consistent portion of all GIST pts, but are under-represented in clinical trials. Data on benefits, tolerance of SU in elderly GIST pts and their specific outcome are very limited. Methods: Charts of elderly pts (≥ 65 yrs)treated with SU in routine clinical practice from 11 Centres of the FSG were reviewed to evaluate the efficacy and safety of SU. Results: 71 elderly GIST pts were reviewed, with a median age of 74, [distributed as 65-74, n=36; 75-84, n=30; ≥ 85, n=5], 41 (57%) men, with median ECOG-PS= 1 (0-2), and median active comorbities of 1 (0-4). SU was administered after progression on first-line Imatinib (400 mg/d for 21 pts, 400 then 800 mg/d for 45 pts) or masitinib (5 pts). SU was started at 50 mg/d 4-wks-on/2 wks-off in 37 pts (52%), at 37.5 mg daily in 32 pts (45%), and at 25 mg daily in 2 pts. All but 2 pts experienced at least one adverse event (AE). Drug related AE were mainly of grade 1 or 2 (298/388, 76%), and medically manageable. Most frequent AE were fatigue (20%), diarrhea (11%), mucositis (7%), abdominal pain (7%), hand-foot syndrome (6%), neutropenia (6%), and hypertension (5%). Permanent dose reduction was reported in 33 pts (46%). In 17 pts (24%) SU was permanently stopped due to grade 3 or 4 AE. ; this occurred within 3 months after starting SU in 10 pts. At a median 36 months follow-up, 53 pts progressed, and 28 pts were alive. The median PFS and OS were 10.2 (0.2-54) and 21 (0.5-77) months, respectively. Univariate analysis showed that age (≤ 80), PS (<1), WBC (≤ 4 Giga/l), Hb and Albumin have a positive impact on OS (all p < 0.04) and PFS (all p < 0.05). In multivariate analysis, Albumin and Hb had an impact on OS and PFS, PS had an impact only on OS, and WBC only on PFS. A correlation was found between comorbidities and Grade 3/4 toxicities, but no correlation between any toxicities and outcome. Conclusions: Compared to data from clinical trials, SU yields similar rates of GIST control and OS in elderly pts despite frequent dose reductions or interruptions. Since comorbidities may increase the risks of AEs, careful follow-up to assess tolerance is particularly indicated in elderly GIST pts.

A multicenter, phase II study of trastuzumab plus capecitabine and oxaliplatin (XELOX) as first-line chemotherapy for HER2-positive advanced gastric cancer: Update results of efficacy and toxicity.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 102-102 ◽  
Author(s):  
Jifang Gong ◽  
Tianshu Liu ◽  
Qingxia Fan ◽  
Li Bai ◽  
Feng Bi ◽  
...  
Keyword(s):  
Treatment Options ◽  
Drop Out ◽  
Chinese Patients ◽  
Her2 Positive ◽  
Stage Design ◽  
Drop Out Rate ◽  
Hand Foot Syndrome ◽  
Grade 3 ◽  
Clinical Trial Information

102 Background: The ToGA study showed trastuzumab plus chemotherapy prolonged OS in patients with HER2-positive AGC. Result of REAL2 study suggested that oxaliplatin may be as effective as cisplatin but more tolerable. To further improve treatment options, we initiated a study to evaluate the efficacy and safety of trastuzumab plus XELOX in Chinese patients with HER2-positive AGC. Methods: Simon two-stage design with primary endpoint of best confirmed response rate by RECIST 1.0 was applied. The sample size is calculated to be 46, assuming H0=40%, H1=60%, a=0.05, b =0.2. Considering 10% drop-out rate, the total number of subjects was planned to be 51. Patients with previously untreated, HER2-positive (IHC2+/Dual SISH positive, or IHC 3+), histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction were eligible. Trastuzumab was administered at a loading dose of 8 mg/kg followed by 6 mg/kg infusion every 3 weeks (q3w). Oxaliplatin was administrated as a 130mg/m2 infusion, q3w, up to 6 cycles. Capecitabine was given orally with 2000mg/m2d, d1-14, q3w. Trastuzumab and capecitabine were continued until disease progression or intolerable toxicity. The NCI-CTCAE version 4.0 is used to evaluate safety profiles. Results: 72 patients (362 patients at 13 centers were screened) were HER2 positive, of which 51 patients were enrolled. The majority of patients were HER2 IHC 3+ (38/51). Response was evaluated in 46 patients, one patient achieved CR and thirty-three patients achieved PR. Till June 2013, 29 patients progressed, 14 cases died, showing PFS of 312 days (95%CI:211-360). The most common AEs that are higher than grade 3 were thrombocytopenia (21.6%), neutropenia (13.7%), anemia (7.84%), leucopenia (3.92%), nausea/vomiting (3.92%), hand-foot syndrome (3.92%). 6 patients possess LVEF decrease by ≥10% and one patient discontinued trastuzumab infusion. Conclusions: The addition of trastuzumab to XELOX was well tolerated and the results demonstrated encouraging efficacy. Survival benefit of this regimen needs further follow-up of patients to be concluded. Clinical trial information: NCT01364493.

ARMOR2: Galeterone in progressive CRPC patients who have failed oral therapy.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 71-71 ◽  
Author(s):  
Mary-Ellen Taplin ◽  
Robert B. Montgomery ◽  
Keyword(s):  
Study Drug ◽  
Oral Steroid ◽  
Open Label ◽  
Phase 2 Trial ◽  
Treatment Naïve ◽  
Psa Response ◽  
Steroid Analog ◽  
Grade 3 ◽  
Clinical Trial Information

71 Background: Galeterone is a first-in-class multitargeted oral steroid analog; it suppresses prostate cancer by a combination of AR modulation (antagonism and degradation) and CYP17 inhibition. Safety and proof of concept of galeterone in CRPC was assessed in ARMOR1. Galeterone was reformulated by spray dry dispersion technology (SDD) to optimize PK and remove food effect. ARMOR2 (NCT 01709734) is an open label, 2-part phase 2 trial that evaluates safety and efficacy of SDD galeterone in 4 populations of CRPC patients. These results report Part 1. Methods: Objectives of Part 1: confirm dose equivalence of SDD formulation with evaluation of PK, safety and PSA response. Metastatic (M1) and non-metastatic (M0) treatment naïve CRPC pts enrolled to groups of 1,700, 2,550 or 3,400 mg PO daily. An abiraterone refractory (Abi-R) group of 3 patients opened at 2,550mg. Results: 28 were enrolled in part 1. Safety: All groups were safe by IMC assessment. There were 4 grade 3 adverse events. 2 were unrelated to study drug. 2 had transient G3 ALT elevations (did not recur with rechallenge). There was no AME: supplemental steroids were not required. G4 angioedema occurred in a pt receiving lisinopril (known association with angioedema). Efficacy: PSA response was improved compared to ARMOR1 (AACR 2012. Taplin et al abstract: CT-07). At early follow up Abi-R pts showed improvements in PSA with 1 PSA30% response, 2 with stablized PSA (decline in PSA-V from +0.44 to -0.39 ng/day). Conclusions: Galeterone in SDD formulation is tolerated at doses up to 3,400mg daily. SDD galeterone provides improved PSA response and durability vs. prior formulation. There is evidence of activity in abiraterone refractory patients. Clinical trial information: 01709734. [Table: see text]

APACT: phase III, multicenter, international, open-label, randomized trial of adjuvant nab-paclitaxel plus gemcitabine (nab-P/G) vs gemcitabine (G) for surgically resected pancreatic adenocarcinoma.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4000-4000 ◽  
Author(s):  
Margaret A. Tempero ◽  
Michele Reni ◽  
Hanno Riess ◽  
Uwe Pelzer ◽  
Eileen Mary O'Reilly ◽  
...  
Keyword(s):  
Disease Free Survival ◽  
Disease Recurrence ◽  
Geographic Region ◽  
Phase Iii ◽  
Lymph Node Status ◽  
Open Label ◽  
Significance Level ◽  
Grade 3 ◽  
Ecog Ps

4000 Background: In metastatic pancreatic cancer (PC), nab-P/G demonstrated significantly longer overall survival (OS) vs G. APACT assessed efficacy & safety of nab-P/G vs G in surgically resected PC. Methods: Treatment (tx)-naive patients (pts) with histologically confirmed PC, macroscopic complete resection, ECOG PS 0/1, & CA19-9 < 100 U/mL were eligible. Stratification factors: resection status (R0/R1), lymph node status (LN+/−), & geographic region. Tx was initiated ≤ 12 wks postsurgery. Pts received nab-P 125 mg/m2 + G 1000 mg/m2 or G 1000 mg/m2 on days 1, 8, 15 of six 28-day cycles. Primary endpoint was disease-free survival (DFS) by independent reviewer (IR); IRs received baseline clinical data & scans. Secondary endpoints were OS & safety. ≈438 DFS events were needed for 90% power to detect an HR for disease recurrence or death of 0.73 with nab-P/G vs G at a 2-sided significance level of 0.05. Results: 866 pts were randomized. Median age was 64 y (range, 34 - 86); most pts had ECOG PS 0 (60%), LN+ (72%), & R0 (76%). 69% of pts completed 6 tx cycles ( nab-P/G, 66%; G, 71%). Median follow up for OS was 38.5 mo. Median IR-assessed DFS (439 events) was 19.4 mo ( nab-P/G) vs 18.8 mo (G) (HR, 0.88; 95% CI, 0.729 - 1.063; stratified log-rank P = 0.1824). Investigator-assessed DFS (571 events) was 16.6 mo ( nab-P/G) vs 13.7 mo (G) (HR, 0.82; 95% CI, 0.694 - 0.965; nominal P = 0.0168). Interim OS (427 events) was 40.5 mo ( nab-P/G) vs 36.2 mo (G) (HR, 0.82; 95% CI, 0.680 - 0.996; nominal P = 0.045). Grade ≥ 3 TEAEs were reported in 86% vs 68% of pts with nab-P/G vs G. The most common grade ≥ 3 hematologic & nonhematologic TEAEs with nab-P/G vs G were neutropenia (49% vs 43%) & fatigue (10% vs 3%). TEAEs led to death in 2 pts in each arm. Conclusions: IR DFS with nab-P/G was not significantly longer vs G; median DFS with G was longer than historical data. DFS by investigator (sensitivity analysis) and interim OS were improved with nab-P/G vs G (HR 0.82 for both). Adjuvant nab-P/G may be an option for pts who are ineligible for FOLFIRINOX. Additional OS follow-up may better support nab-P/G as an option in the adjuvant setting. Clinical trial information: NCT01964430.

Pembrolizumab for metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel: Updated analysis of KEYNOTE-199.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 216-216 ◽  
Author(s):  
Emmanuel S. Antonarakis ◽  
Jeffrey C. Goh ◽  
Marine Gross-Goupil ◽  
Ulka N. Vaishampayan ◽  
Josep M. Piulats ◽  
...  
Keyword(s):  
Antitumor Activity ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Toxicity Response ◽  
Duration Of Response ◽  
Previously Treated ◽  
Grade 3 ◽  
Ecog Ps ◽  
Clinical Trial Information

216 Background: Previously presented data from cohorts (C) 1-3 of the phase 2 KEYNOTE-199 study (n = 258; NCT02787005) showed that pembrolizumab monotherapy had antitumor activity and acceptable safety in patients (pts) with mCRPC previously treated with next-generation hormonal agents (NHAs; eg, abiraterone, enzalutamide) and docetaxel. Activity was observed for both PD-L1–positive and negative cohorts and in RECIST-measurable and bone-predominant disease. We present data from KEYNOTE-199 C1, C2, and C3 based on longer-follow-up. Methods: C1 enrolled 133 pts with RECIST-measurable, PD-L1–positive disease, C2 enrolled 66 pts with RECIST-measurable, PD-L1–negative disease, and C3 enrolled 59 pts with nonmeasurable, bone-predominant disease. All pts had ECOG PS 0-2 and received ≥1 NHA and 1-2 prior chemotherapies including docetaxel. Pembrolizumab 200 mg Q3W was given for 35 cycles or until PD or intolerable toxicity. Response was assessed Q9W in yr 1, then Q12W. Primary end point was ORR per RECIST v1.1 by central review. Key secondary end points included DCR (CR + PR + SD ≥6 mo), duration of response (DOR), OS, and safety. Results: Median follow-up as of Aug 21, 2018, was 9.5 mo in C1, 7.9 mo in C2, and 14.1 mo in C3. ORR (95% CI) was 5% (2-11) in C1 and 3% ( < 1-11) in C2. DCR was 10% in C1, 9% in C2, and 22% in C3 per RECIST v1.1. Median (range) DOR was not reached (1.9-21.8+ mo) in C1 and 10.6 mo (4.4-16.8) in C2; KM estimates of DOR ≥12 mo were 71% and 50%. Median (95% CI) OS was 9.5 mo (6.4-11.9) in C1, 7.9 mo (5.9-10.2) in C2, and 14.1 (10.8-17.6) in C3. 12-mo OS rates were 41% in C1, 35% in C2, and 62% in C3; 18-mo rates were 30%, 21%, and 36%. Grade 3-5 drug-related AE rates were 15% in C1, 14% in C2, and 17% in C3. There were 2 drug-related deaths (n = 1 each sepsis and pneumonitis). Conclusions: Pembrolizumab shows antitumor activity and disease control with acceptable safety in RECIST-measurable and bone-predominant mCRPC previously treated with NHAs and docetaxel. Responses are durable, and the observed OS benefit is promising. Clinical trial information: NCT02787005.

scholarly journals Efficacy, safety and prognostic factors in patients with refractory metastatic colorectal cancer treated with trifluridine/tipiracil plus bevacizumab in a real-world setting

2022 ◽  
Author(s):  
Nieves Martínez-Lago ◽  
Teresa Calleja Chucla ◽  
Beatriz Alonso de Castro ◽  
Rafael Varela Ponte ◽  
Cristina Reboredo Rendo ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Free Survival ◽  
Common Grade ◽  
Third Line ◽  
Grade 3

Abstract We evaluated the efficacy and safety of trifluridine/tipiracil (TAS-102) plus bevacizumab in treating refractory metastatic colorectal cancer (mCRC) in a retrospective, observational study. Patients refractory or intolerant to standard therapies received TAS-102 (30–35 mg/m2 twice daily on days 1–5 and days 8–12 every 28 days) plus bevacizumab 5 mg/kg on days 1 and 15. Clinical and pathological characteristics, overall response rate (ORR) and disease control rate (DCR), overall survival (OS) and progression-free survival (PFS) data were collected and analysed. Thirty-five patients were treated from July 2019 to October 2021 (median age 64 years). The majority of patients (68.6%) were receiving TAS-102 plus bevacizumab as third-line treatment. Patients received a median of 4 (range 2–15) cycles of treatment. Among 31 patients evaluable for response (88.6%), ORR and DCR were 3.2% and 51.6%, respectively. After a median 11.6 months’ follow-up, median PFS was 4.3 (95% confidence interval [CI] 3.4–5.1) months and median OS was 9.3 (95% CI 6.6–12.1) months. The most common grade 3–4 toxicities were neutropenia, asthenia and nausea/vomiting, and there were no treatment-related deaths. This real-world study confirms the efficacy and safety of TAS-102 plus bevacizumab in patients with refractory mCRC.

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