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.

Results of a phase II trial of cetuximab + XELIRI as first-line therapy of patients with advanced and/or metastatic colorectal cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4094-4094
Author(s):  
T. H. Cartwright ◽  
P. Kuefler ◽  
A. Cohn ◽  
W. Hyman ◽  
M. Yoffe ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Allergic Reaction ◽  
Metastatic Colorectal Cancer ◽  
First Line ◽  
Prior Therapy ◽  
First Line Therapy ◽  
Duration Of Response ◽  
Grade 3 ◽  
Ecog Ps ◽  
Dose Reductions

4094 Background: We have previously shown that capecitabine/irinotecan (XELIRI) is effective and well-tolerated in metastatic colorectal cancer (mCRC). Cetuximab, a monoclonal IgG1 antibody that binds to the extracellular domain of EGFR, is active in mCRC alone or in combination with chemotherapy. This study was designed to evaluate if cetuximab (Erbitux®) added to XELIRI improves outcome in first-line treatment of mCRC. Methods: Subjects had histologically confirmed colorectal adenocarcinoma with T4 lesions that were unresectable after preoperative chemoradiation therapy and/or metastases. The study regimen was capecitabine 1700 mg/m2 (850 mg/m2 PO BID Days 1–14), irinotecan 200 mg/m2 IV Day 1 every 3 weeks, and weekly cetuximab (initial dose 400 mg/m2 IV over 120 minutes, subsequent doses 250 mg/m2 over 30 minutes). Results: Between February and October 2005, 70 subjects enrolled. Baseline characteristics: 43 males (61%), median age 61.5 years, and ECOG PS 0/1= 66%/34%; 94% of subjects had adenocarcinoma. Prior therapy; surgery (91%), chemotherapy (20%), or radiotherapy (7%). Responses (pts >2 cycles) were; CR (4%), PR (36%), SD (40%) and PD (20%); 15 patients failed treatment; (n=4 allergic reaction, n=2 MD request, n=2 withdrew consent, n=2 Grade 4 neutropenia, and n=5 other AEs). The overall response rate was 40% and the disease control rate was 80%. Median duration of response was 8.8 months (range, 2.6–15.1) and median time to response was 2.0 months (range, 1.2–8.3). 64% of patients remain alive; of the 25 deaths, 84% were due to PD. No death was drug related. The most frequent Grade 3 and 4 treatment-related adverse events (AEs) included: diarrhea (25%), neutropenia (18%), nausea/vomiting (12%), rash and dehydration (9%, each), HFS and fatigue (7%), and allergic reaction (6%). 54% of patients required dose reductions. To date, 64 patients (91%) have gone off study, primarily due to PD (39%) or AE (33%); 3 patients remain on treatment. Conclusions: The combination of cetuximab and XELIRI is feasible and tolerable in first line mCRC. Toxicities are expected and manageable with dose reductions/delay. Funded in part by Bristol-Myers Squibb, Plainsboro, NJ. No significant financial relationships to disclose.

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 study of capecitabine and irinotecan combination chemotherapy in patients with advanced gastric cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14037-14037
Author(s):  
J. Baek ◽  
J. Kim ◽  
Y. Chae ◽  
Y. Cho ◽  
S. Sohn ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Combination Chemotherapy ◽  
Overall Response Rate ◽  
Combination Regimen ◽  
Time To Progression ◽  
First Line ◽  
Hand Foot Syndrome ◽  
Grade 3

14037 Background: Several studies have shown the efficacy of capecitabine and irinotecan combination chemotherapy for advanced colorectal cancer, while no results have yet been reported for advanced gastric cancer. Accordingly, the current study evaluated the efficacy and safety of a combination regimen of capecitabine plus irinotecan in patients with advanced gastric cancer. Methods: Patients with previously untreated metastatic or recurrent, measurable gastric cancer received oral capecitabine 1000 mg/m2 twice daily from day 1 to 14 and intravenous irinotecan 100 mg/m2 on days 1 and 8, based on a 3-week cycle. Results: Forty-one patients were enrolled in the current study, among whom 38 were assessable for efficacy and 40 assessable for toxicity. Three complete responses and 16 partial responses were confirmed, giving an overall response rate of 46.3%. At a median follow-up of 269 days, the median time to progression and overall survival were 5.1 months and 8.6 months, respectively. Grade 3/4 neutropenia occurred in 4 patients and grade 3 febrile neutropenia was observed in 2 patients. Grade 3 diarrhea and grade 2 hand-foot syndrome occurred in 6 patients and 8 patients, respectively. Conclusions: The combination of capecitabine and irinotecan was found to be well tolerated and effective in patients with advanced gastric cancer. Accordingly, this regimen can be regarded as an important first-line treatment option for advanced gastric cancer. No significant financial relationships to disclose.

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]

First-Line Treatment with Rituximab Combined with Intravenous or Oral Fludarabine for Patients with Extranodal Mucosa Associated Lymphoid Tissue (MALT) Lymphoma.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2007-2007
Author(s):  
Antonio Salar ◽  
Eva Domingo-Domènech ◽  
Cristina Estany ◽  
Miguel Canales ◽  
Octavio Servitge ◽  
...  
Keyword(s):  
Malt Lymphoma ◽  
Univariate Analysis ◽  
Progression Free Survival ◽  
First Line ◽  
The Third ◽  
First Line Therapy ◽  
Improved Outcomes ◽  
Significant Addition ◽  
Grade 3

Abstract Backgroud: Synergistic antitumor effect with combination of fludarabine and rituximab has been demostrated on MALT cells. Addition of rituximab to other drugs has improved outcomes in several types of NHL without a significant addition of toxicity. Our aim was to evaluate the safety and efficacy of rituximab combined with fludarabine (RF) in first-line therapy for extranodal MALT lymphoma. Patients and methods: Adult patients with untreated extranodal MALT lymphoma who were included and received rituximab 375 mg/m intravenously (IV) on day 1 and fludarabine 25 mg/m (IV) given on days 1–5 (days 1–3 in &gt; 60 years), every 4 weeks; after the first cycle, oral fludarabine was permitted. After 3 cycles, a work-up was done. Patients in complete remission (CR) received an additional cycle and, if partial remission (PR), a total of 6 cycles. Results: 22 patients were included. Characteristics: median age: 60 years (32–83); 45% male; PS 0–1 (100%); site of lymphoma origin: gastric (61%) and extragastric (39%); stage: I (45%), II1 (23%), II2 (5%) and IV (27%). A total of 101 cycles of RF were administered and 21 pts were evaluable for response. After the third cycle, 13 pts (62%) achieved CR and 8 pts (38%) PR. At the end of therapy, 19 pts (90%) achieved CR and 2 pts (10%) PR. Univariate analysis identified primary extragastric disease as an adverse factor to reach CR after 3 cycles of RF (HR 23.3 (95% CI, 2.0–273.3)). The median follow-up time was 23 months (95% CI, 18–27 months). Progression free survival (PFS) at 24 months was 88 % (95% CI, 80–100%). PFS at 24 months in gastric and extragastric MALT lymphoma were 100% and 79%, respectively. Tolerance to oral fludarabine was excellent. Mild neutropenia was the most common toxicity, usually presenting after the third cycle and 2 pts had prolonged mild thrombocytopenia. No grade 3–4 infections were observed. Conclusions: Immunochemotherapy with RF, either with intravenous or oral fludarabine, achieves a high CR rate in both gastric and extragastric MALT lymphoma, although the firsts responded faster. With only four cycles of RF, two thirds of patients achieves CR. RF is associated with a good safety profile being mild granulocytopenia and thrombocytopenia the main adverse events. The long-term benefit of this therapy will require prolonged follow-up.

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.

N9741: Survival update and prognostic factor analysis of oxaliplatin (Ox) and irinotecan (Iri) combinations for metastatic colorectal cancer (MCRC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4067-4067 ◽  
Author(s):  
H. K. Sanoff ◽  
D. J. Sargent ◽  
M. E. Campbell ◽  
R. F. Morton ◽  
C. S. Fuchs ◽  
...  
Keyword(s):  
Prognostic Factor ◽  
Prognostic Model ◽  
Performance Status ◽  
Time To Progression ◽  
First Line ◽  
Logistic Regression Models ◽  
Kaplan Meier ◽  
Specific Outcome ◽  
Grade 3

4067 Background: N9741 randomized 1691 patients (pts) to seven 5FU, Ox and Iri containing regimens for MCRC. After 20.4 months median follow-up, FOLFOX and IROX improved time to progression (TTP) and overall survival (OS) compared to IFL. Here we update OS and TTP, and report an analysis of factors prognostic of pt outcome. Methods: 5 yr OS and TTP were calculated by Kaplan-Meier per treatment (rx) arm. Pt factors [rx arm, age, gender, prior adjuvant rx, body mass index (BMI), performance status (PS), number of disease sites (#sites), neutrophil count (ANC), hemoglobin, platelets, bilirubin, alkaline phosphatase (ALK), aspartate aminotransferase (AST)] were assessed for univariate association with OS, TTP, response rate (RR), and any grade =3 toxicity. Associated factors were included in multivariate Cox and logistic regression models. Results: After a median follow-up of 4.3 yrs, FOLFOX treated pts were more likely to live 5 yrs, 9.2% versus 5.4% for IROX (p=.016) and 3.8% for IFL (p<.001). Median TTP was also significantly longer in the FOLFOX arm, 9.2 mo vs 6.5 mo for IROX (p=<.001) and 6.0 mo for IFL (p=<.001). The prognostic model found higher PS, ANC and ALK, and more disease sites were prognostic of worse OS (see table ). Age = 70 was associated with poorer survival (HR death 1.33, p=.03), but not TTP, RR, or grade =3 toxicity. FOLFOX rx was the most powerful prognostic factor for TTP and OS. The odds of grade =3 toxicity were significantly higher in FOLFOX treated pts (OR 1.65, p<.001) and lower in men (OR .63, p<.001). No significant interactions between rx arm and pt factors were present, suggesting no factor examined is predictive of rx-specific outcome. Conclusions: 9% 5 yr OS in MCRC pts treated with first-line FOLFOX sets a new benchmark. We confirmed pre-rx PS, WBC, and ALK are prognostic for OS, though FOLFOX rx was the strongest prognostic factor. No factor was associated with differential outcome or toxicity by rx arm, thus these factors cannot be used to guide rx selection. [Table: see text] [Table: see text]

Advanced hepatocellular carcinoma (HCC) treated with sunitinib (Su) and transarterial chemoembolization (TACE): Phase II trial final report.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 275-275 ◽  
Author(s):  
Renuka V. Iyer ◽  
Garin Tomaszewski ◽  
Yuhsin V Wu ◽  
Boris W. Kuvshinoff ◽  
Adrienne E. Groman ◽  
...  
Keyword(s):  
Final Report ◽  
Advanced Hepatocellular Carcinoma ◽  
Phase 2 Study ◽  
Progression Of Disease ◽  
Prospective Phase ◽  
Grade 3 ◽  
Ecog Ps ◽  
Tace Treatment ◽  
Dose Reductions

275 Background: TACE and anti-angiogenic agents have individually been effective in inoperable HCC. In this prospective phase 2 study, the effects and PFS of Su+TACE was evaluated. Methods: Eligibility: ECOG PS 0, 1, inoperable HCC, Child Pugh (CP) A/B, platelets >100K, bilirubin < 2 and no contraindications to TACE. Treatment: Cycle (C) 1 -Su 37.5mg po days (d)1-7; - TACE with doxorubicin in lipodiol on d8;- Su 37.5mg po qd d15-36; - 2 wks off C2 onwards - Su 4 wks on (dose escalation to 50mg in pts without grade 3 toxicities);- 2 wks off DCE-MRI, sVEGFr, monocytes, and Su PK were assessed at d0, 8, 10, and 36. Results: Characteristics of the 16 pts were: median age 74 yr (range 40-86), all with CP A cirrhosis (etiology: hepB: 2, hepC: 6, ETOH: 1, unknown: 7), and PS 0: 12, PS 1: 4. 10 pts had liver only and 6 pts had extrahepatic disease. Median PFS was 8 mo (95% CI 4.3-9.3) and OS was 14.9 mo (95% CI 6.3-27.1) with a median follow up of 12.8 mo (5 pts still alive) receiving a median of 3 cycles (range 1-7). Responses by RECIST criteria were PR: 2, SD: 11 and PD: 3 for total clinical benefit of 81%. DCE-MRIs pts (8) showed median Ktrans change of -20% after d7 of Su and a further 7% after TACE+Su. There was concurrent decrease in viable tumor, 3% (d8) and 15% (d36) respectively. Steady-state Su concentration ranged from 20-150 ng/ml, which is above the IC50 values of 4-30 ng/ml for VEGF inhibition. PK/PD modeling estimated a Su IC50 values of 15 and 10 ng/ml to modulate Ktrans and AUC90. sVEGFR2 levels change with Ktrans and AUC90. Median monocyte counts of 0.4x109/L decreased by 50% on d36 after TACE. 11 pts (69%) had grade 3/4 toxicities attributable to Su. Of a total of 57 events, the most frequent (n>5) were thrombocytopenia (10), amylase/lipase increase (9), lymphopenia (7), and fatigue (6). Dose delays and dose reductions occurred in 13 and 3 pts respectively. Reasons for discontinuing therapy were toxicity (7), progression of disease (7), and withdrawal of consent (2). Conclusions: Improvement in PFS and OS was seen with acceptable toxicity in the first study of Su + TACE in HCC. In addition, it shows a relationship between Su concentration and Ktrans, AUC90, sVEGFR2 and monocytes; with additional decrease seen after TACE.

Phase II clinical trial of XELOX as first line treatment for patients with unresectable or metastatic gastric cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15062-15062
Author(s):  
R. Xu ◽  
B. Han ◽  
Y. Shi ◽  
J. Xiong ◽  
Y. Li ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Objective Response ◽  
Metastatic Gastric Cancer ◽  
Line Treatment ◽  
First Line ◽  
Hand Foot Syndrome ◽  
Grade 3 ◽  
First Line Treatment

15062 Background: The survival of advanced gastric cancer remains poor, while no chemotherapy regimen was recognized standard. Oxaliplatin and Capecitabine (Xeloda) have demonstrated promising antitumor efficacy in advanced colorectal cancer. The present study was conducted to further evaluate the efficacy and safety of XELOX (Oxaliplatin and Xeloda) regimen in gastric cancer. Methods: Patients with unresectable or metastatic gastric cancer were enrolled into this study. They all receive the XELOX regimens (Oxaliplatin 130mg/ m2 intravenously in 2 hours on day 1 followed by oral capecitabine 1000mg/ m2 twice daily for 14 days every 3 weeks).We evaluated the response every 2 cycles. Results: The median age of the total enrolled 45 patients was 55 years (range, 22–82 years), including 32 male and 13 female. They received a median of 5 cycles (range, 2–8 cycles) of XELOX. 21 of 45 patients (46.7%) achieved an objective response, 1 patient (2.2%) had completed response. 17 patients (37.8%) experienced stable disease. Median time to tumor progression (TTP) and median overall survival were not available yet due to the further follow-up needed. Most toxicity events were mild to moderate in XELOX regimen, with grade 3/4 neutropenia of 8.9 %, thrombocytopenia of 6.7%, anemia of 11.1%, hand-foot syndrome of 6.7 % and diarrhea of 6.7 %. Grade 3 neuropathy was 4.4%. The patients with advanced gastric cancer had a good tolerance to this chemotherapy. Conclusions: XELOX is a highly effective first-line treatment for unrsectable and metastatic gastric cancer. The response rates in this trial seems to be similar to those observed with FU/leucovorin/oxaliplatin combinations. XELOX is tolerable well in the treatment of advanced gastric cancer. No significant financial relationships to disclose.

Second-line gemcitabine plus nab-paclitaxel (G+A) for advanced pancreatic cancer (APC) after first-line FOLFIRINOX: Single institution retrospective review of efficacy and toxicity.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 344-344 ◽  
Author(s):  
Yue Zhang ◽  
Howard S. Hochster ◽  
Stacey Stein ◽  
Jill Lacy
Keyword(s):  
Retrospective Review ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Cancer Center ◽  
Second Line ◽  
Single Institution ◽  
First Line ◽  
Grade 3 ◽  
Ecog Ps ◽  
Dose Reductions

344 Background: Gemcitabine (G) plus paclitaxel protein-bound particles for injectable suspension (Abraxane, A) is an active first line regimen for APC based on improved efficacy compared to G (Van Hoff, DD et al. J Clin Oncol 31, 2013 [suppl;abstr 4005]). However, there is a paucity of data regarding efficacy of G+A in pts who received prior FOLFIRINOX. To assess efficacy and tolerability of 2nd line G+A, we reviewed our single institution experience with G+A in APC pts who received 1st line FOLFIRINOX. Methods: We conducted a retrospective review of dose, toxicity, efficacy of second line G+A in FOLFIRINOX-treated APC pts treated at Yale Cancer Center between 12/2011 and 08/2013. Pts were treated until progression, unacceptable toxicity, or pt preference. Doses were at treating physician’sdiscretion. Dose densities were compared to full doses (A 125 mg/m2 + G 1000 mg/m2 days 1, 8,15 q 4 wks). Response rate, med time to treatment failure (TTF), med overall survival (OS) were calculated. Results: 23 pts were treated with G+A after 1st line FOLFIRINOX. Pts characteristics: metastatic, 18; locally advanced, 5; med age, 61 (range 50-74);male, 9; ECOG PS ≤1, 22; med # FOLFIRINOX cycles, 12 (range 5-46). Med interval from FOLFIRINOX to G+A was 5 wks (range 1.7-40.3). Responses by RECIST were: PR, 2 (8.7%); SD for ≥7 wks, 8 (34.8%); PD, 10 (43.4%); ineval, 3 (13.1%). 9 (39%) and 8 (34%) pts had >30% decrease in CA 19-9 and CEA, respectively. 13 pts died, 6 pts stopped G+A, 4 pts are still receiving G+A. Med TTF was 11 wks (range 1-35). Med OS was >17.9 wks (range 2.1-69.6). All pts had initial dose reductions of G or A; 7 and 12 pts required further dose reductions with A and G, respectively. Dose densities were 56.9% and 63.5% for A and G, respectively. Grade ≥3 hematologic toxicities included neutropenia 17%, anemia 26%, thrombopenia 26%. Conclusions: In this single institution pt population, G+A has limited activity after FOLFIRINOX. Most of our pts received FOLFIRINOX for >6 months and were still able to receive a 2nd line doublet. Most required dose reductions for cytopenias, but this sequence was tolerable. In this setting, an additional 11 wks med TTF is about half of the TTF in 1st line G+A and may be clinically valuable.

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