Non-Measurable Lesion

2020 ◽  
Author(s):  
Keyword(s):  
Measurable Lesion

Paclitaxel, an Active Agent in Nonsquamous Carcinomas of the Uterine Cervix: A Gynecologic Oncology Group Study

2001 ◽  
Vol 19 (5) ◽  
pp. 1275-1278 ◽  
Author(s):  
John P. Curtin ◽  
John A. Blessing ◽  
Kenneth D. Webster ◽  
Peter G. Rose ◽  
Allan R. Mayer ◽  
...  
Keyword(s):  
Overall Response Rate ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Gynecologic Oncology ◽  
Active Agent ◽  
Complete Response ◽  
Gynecologic Oncology Group ◽  
Starting Dose ◽  
Dose Limiting Toxicity ◽  
Measurable Lesion

PURPOSE: A phase II trial of paclitaxel was initiated in advanced nonsquamous carcinoma of the cervix to determine its activity in patients who had failed standard chemotherapy. PATIENTS AND METHODS: Eligible patients had at least one measurable lesion. The starting dose of paclitaxel was 170 mg/m2 (135 mg/m2 for patients with prior pelvic radiation) given as a 24-hour continuous intravenous infusion with courses repeated every 3 weeks. Dose escalation to 200 mg/m2 and de-escalation to 110 mg/m2 were allowed based on adverse effects. RESULTS: In this trial, 42 assessable patients were initially entered onto the study, and 13 responses were seen; four patients had a complete response, and nine patients had a partial response. The overall response rate was 31%. The primary and dose-limiting toxicity was neutropenia. CONCLUSION: The response rate to paclitaxel exceeds the rates reported using other single agents in nonsquamous carcinoma of the cervix.

What can we do for gastrointestinal cancer patients with poor performance status (PS)?

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19629-19629
Author(s):  
K. Shitara ◽  
M. Munakata ◽  
O. Muto ◽  
M. Kasai ◽  
Y. Sakata
Keyword(s):  
Cancer Patients ◽  
Tumor Markers ◽  
Gastrointestinal Cancer ◽  
Survival Benefit ◽  
Performance Status ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Ecog Ps ◽  
To Receive ◽  
Measurable Lesion

19629 Background: The prognosis of advanced gastrointestinal cancer patients, especially those with poor PS, is generally dismal. Needless to say, such patients are ineligible for participation in clinical studies. However, there are many patients with poor PS who wish to receive chemotherapy. Methods: From June 2000 to October 2006, a total of 508 patients with advanced cancer, including 304 gastrointestinal cancer patients, were treated by chemotherapy in our hospital. Of these, 110 gastrointestinal cancer patients (gastric=35, colorectal=30, pancreatic=26, biliary tract=11, esophageal=8) had poor PS (ECOG PS 3 = 68 patients, PS 4 = 42 patients). In 103 patients with at least one measurable lesion, a partial response according to RECIST criteria was obtained in 13 patients (12.6%). In 60 patients with ascites (47 patients), pleural effusion (25 patients), or both (12 patients), 11 of the patients (18.3%) achieved decreased fluid accumulation. A decline in tumor markers (>25%) was observed in 28 patients. Improvement in PS was seen in 13 patients (11.8%). As a result, 35 patients (31.8 %, including 9 patients with PS 4) achieved a tumor response, a decrease in accumulated fluid, or a decline in tumor markers, which resulted in a survival benefit compared to the other 75 patients without effect (6.4 months vs. 2.3 months, p<0.001). Alleviation of some symptoms was observed in 28 out of 98 symptomatic patients (30.4%). A better response and/or a decline in tumor markers significantly correlated with alleviation of symptoms (p<0.001). No treatment related death was seen. Conclusions: With regard to response rate, chemotherapy was rarely effective for patients with advanced gastrointestinal cancer with poor PS. However, more than a few patients gained a certain survival benefit and alleviation of symptoms. Thus, chemotherapy may be warranted in cases of patients with advanced gastrointestinal cancer who wish to receive chemotherapy despite the low possibility of response. No significant financial relationships to disclose.

Phase II window study on rituximab in newly diagnosed pediatric mature B-cell non-Hodgkin lymphoma (NHL)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 10000-10000 ◽  
Author(s):  
A. Reiter ◽  
A. Meinhardt ◽  
B. Burkhardt ◽  
M. Zimmermann ◽  
A. Borkhardt ◽  
...  
Keyword(s):  
B Cell ◽  
Phase Ii ◽  
Single Agent ◽  
Newly Diagnosed ◽  
Response Evaluation ◽  
Non Hodgkin Lymphoma ◽  
Pre Treatment ◽  
Study Plan ◽  
Measurable Lesion ◽  
Performance Scale

10000 Background: Pediatric mature B-cell NHL differ from aggressive B-NHL of adults in terms of biology and treatment outcome. In contrast to adults, rituximab (Rx) is not established in the treatment of pediatric B-NHL has not be determined yet. Even the activity of Rx in pediatric B-NHL is not determined. We conducted a phase II window study to examine the activity of Rx in newly diagnosed pediatric B-NHL. Methods: Eligibility: age < 19 y, CD20 + B-NHL, ≥ 1 measurable lesion/s, informed consent. Exclusion: Lansky performance scale 5, pre-treatment, impaired renal-, heart-, liver-function, hepatitis B, pre-existing disease, pregnancy. Treatment: Rx 375 mg/m2 IV at day 1; concomitant therapy: Rasburicase, steroids only for anaphylaxis, intrathecal (IT) triple drug at days 1, 3 for CNS+ pts only. Begin of chemotherapy at day 5. Response evaluation: product of 2 perpendicular diameters of 1 - 3 index lesions/% blasts in BM/PB within 24 h prior to Rx and at day 5: responder (RP): at least 1 lesion with at least objective effect (decrease of ≥25%) and no progress (increase of ≥25 %) at other sites. Study plan: Simon 2-stage phase II with α and β = 5%. Response rate (RR) for poor activity was set to 45%, for good activity 65%. 33 pts entered the first stage, final evaluation after 79 pts. Results: One hundred thirty-six pts were enrolled from 04/04–08/08. NTC °3/4 toxicities: general condition 16%, fatigue 13%, anaphylaxis (chill/fever/bronchospasm) 6 (1/2/4)%, infection 3%, S-GOT/GPT 10%, acute tumor lysis (ATL) 7%, capillary leakage (0), toxic death (0). Forty-nine pts were not evaluable for response: Withdrawal (anaphylaxis 8, ATL 2, suspected progression, not verified 4, other 2), IT therapy in CNS- pts (8), corticosteroids (3), technical inadequacy of response evaluation (21), no index lesion (1). Of the 87 evaluable pts 37 were RPs (42.5%, 95%-CI 32% - 54%). RR by histology: BL/B-ALL 29/68, DLBCL 6/14, juvenile follicular lymphoma 1/2, PMBCL 1/1, B-NHL nfs 0/2. Fifty pts were non-RPs. Conclusions: Although the RR was lower than requested Rx as single agent is active in pediatric B-NHL. No significant financial relationships to disclose.

Safety and efficacy during first line with cetuximab in KRAS wild-type metastatic colorectal cancer (mCRC): Results of a large prospective multicenter cohort carried out by the premium French observational study.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 555-555
Author(s):  
Laurent Mineur ◽  
Gilles Seni ◽  
Laurent Miglianico ◽  
louis-Marie Dourthe ◽  
Nathalie Bonichon ◽  
...  
Keyword(s):  
Tumor Location ◽  
Drug Discontinuation ◽  
Wild Type ◽  
First Line ◽  
Eligibility Criteria ◽  
Cutaneous Toxicity ◽  
Safety And Efficacy ◽  
Patient Request ◽  
Health Institutions ◽  
Measurable Lesion

555 Background: Cetuximab improves benefit in patients with kras wild type when added to CT for mCRC (Crystal, opus, celim trials). In order to assess the safety and efficacy of cetuximab in daily-practices a national prospective observational multicenter study was performed. Methods: Physicians (n=94), in health institutions (44 public and 46 private hospitals, 4 cancer centers) enrolled prospectively 502 patients. The eligibility criteria were kras wild type mCRC treated with cetuximab in combination with CT as first-line regimen and at least one measurable lesion. Data are available at 3 months, for 496 patients enrolled between september 2009 to march 2012. Results: Mean age 65,7 years old, 62.9% male, ECOG score 0-1 88.1%, 2-3 11.9%, metastases site were liver 70%, lung 26% and others unlimited 39%. Resectable mCCR 10.6%, potentially resectable metastases 33.9% and unresectable 55.5%. Primary tumor location colon: right 20.9%, transverse 6%, left 35.3%, rectum 30.5%, others 7.3%. Primary cancer was resected in 66 % (n=332), 25% (n=125) received adjuvant CT. Cetuximab was administrated respectively every week(20.2%) or two weeks (79.8% of patients). CT regimens were folfiri 51.8%, folfox 4 36.5%, others 11.7%. At 3 months response rate was complete in 4.6%, partial 44.9%, stable 34%, progression disease 16.5%. Reasons for specific cetuximab treatment discontinuation (n=207) were progressive disease 35.3%, therapeutic break 23.2%, all grade cutaneous toxicity and allergic reaction 15.9%, patient request 2.9%, surgery recruitment 20% radiotherapy, radiofrequency and others 2.7%. Adverse events in grade 2 and 3-4 were respectively neutropenia (9.4%;7.9%), anemia (8.5%;1.4%), thrombocytopenia (2.6%;1%), diarrhea (10.8%;5.3%) vomiting (5.3%;2.2%), folliculitis (17.9%;3%), xerosis (13.3%;2%), paronychia (5%;0.9%), allergy 3.4%. Conclusions: Values reported are consistent with those previously identified trials and can better understand the reasons of drug stopping. The study continues to evaluate prognostic factors influencing response, toxicity and drug discontinuation.

“CHARTA”: FOLFOX/Bevacizumab vs. FOLFOXIRI/Bevacizumab in advanced colorectal cancer—Final results, prognostic and potentially predictive factors from the randomized Phase II trial of the AIO.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3533-3533 ◽  
Author(s):  
Hans-Joachim Schmoll ◽  
Fabian Maximilian Meinert ◽  
Franziska Cygon ◽  
Benjamin Garlipp ◽  
Christian Junghanss ◽  
...  
Keyword(s):  
Predictive Factors ◽  
Drug Combination ◽  
Advanced Colorectal Cancer ◽  
Phase Ii Trial ◽  
Exact Test ◽  
Randomized Phase Ii ◽  
Predictive Risk ◽  
Measurable Lesion ◽  
Clinical Trial Information

3533 Background: FOLFOXIRI/Bevacizumab (Bev) is superior to FOLFIRI/Bev in the TRIBE trial (F Loupakis, NEJM 2014). The CHARTA trial was developed parallel to TRIBE with the same 4-drug-protocol but vs. FOLFOX/B ev as control arm. Methods: From 7/11 to 12/14 250 patients were randomized, including ECOG 0-2, ≥ 1 measurable lesion > 1cm, stratified by ESMO-Group 1,2,3 (HJ Schmoll, Ann Oncol 2012). Induction: 6 months, maintenance Capecitabine+Bev until progression or max.12 months, at P reinduction by investigators decision. 25% dose reduction was allowed in cycle 1 + 2 on the investigator’s discretion. Primary EP: significant improvement of PFS-rate @ 9 months (p<0.1, 2-sided Fisher’s-exact test); secondary EP: RR, PFS, OS, toxicity. Results: 241 pts. (1 not elig., 8 prot. violation) are evaluable after a follow up of 31.4 (0.1-51) months. m/f: 65%/35%, age 61y (21-82), ECOG 0-1/2: 96%/4%. The Primary Endpoint was met: PFS @ 9 months 56% vs. 68%, p= 0.086. PFS was improved: 9.8 vs. 12.0 months, HR 0.7 (ns.), identical to TRIBE with 9.7 vs. 12.1 months. Response rate (A/B): CR: 5%/5%, CR/PR 60%/70%, SD 25%/21%, PD 14%/9%. Final OS will be available at the meeting. Toxicity was low to moderate without major differences except ° ¾ diarrhea (12%/16%) and neutrophils (14%/20%). Clinical/molecular prognostic or predictive factors are equally distributed (stratification by ESMO groups) (see table). There are major, but mostly not significant differences in RR/ PFS in most subgroups, however, not strong enough to safely identify patients with high potential to benefit from the 4-drug combination. Therefore, a multivariate analysis to model a common prognostic and predictive risk score is ongoing and will be presented at the meeting. Conclusion: “CHARTA” supports the superiority of FOLFOXIRI/Bev. A combined prognostic and predictive classification is required to better select those patients with most potential benefit from the 4-drug combination. Clinical trial information: NCT01321957. [Table: see text]

Phase 1 study of the safety and efficacy of INCB050465 combined with obinutuzumab and bendamustine for relapsed or refractory (R/R) follicular lymphoma (FL) (CITADEL-102).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS7578-TPS7578 ◽  
Author(s):  
Morton Coleman ◽  
Antonio Salar ◽  
Javier Munoz ◽  
Natalie Galanina ◽  
Thea Faivre ◽  
...  
Keyword(s):  
B Cell ◽  
Phase 1 ◽  
Maximum Tolerated Dose ◽  
Aggressive Lymphoma ◽  
Cell Transplant ◽  
Safety And Efficacy ◽  
Pet Ct ◽  
Ecog Ps ◽  
Fdg Pet Ct ◽  
Measurable Lesion

TPS7578 Background: Aberrant PI3Kδ activation is implicated in B-cell non-Hodgkin lymphomas (NHL) including FL, the most common indolent subtype. INCB050465, a selective PI3Kδ inhibitor, is being evaluated in an ongoing phase 1/2 study as monotherapy for r/r B-cell NHL, including FL (ASH 2016; Abstract 4195). Obinutuzumab plus bendamustine is approved for patients (pts) with rituximab-refractory FL. This phase 1 cohort expansion study will assess the safety, efficacy, and pharmacokinetics of INCB050465 combined with obinutuzumab and bendamustine in pts with r/r FL (NCT03039114). Methods: Eligible adults will have documented CD20+ FL r/r to 1–4 prior treatments (must include rituximab), ≥1 measurable lesion ( > 1.5 cm in ≥1 dimension), ECOG PS ≤2, and adequate hematologic, hepatic and renal function. Exclusion criteria will include: transformation of FL to aggressive lymphoma or receipt of allogeneic stem cell transplant (SCT) ≤6 months (or having graft-versus-host-disease after allogeneic or autologous SCT ≤3 months) before study start; receipt of any PI3K inhibitor, obinutuzumab, or bendamustine ≤12 months, or rituximab ≤1 month prior to study. Part 1 (safety run-in) will use a 3+3 design. Pts will receive INCB050465 PO at a dose of 20 mg QD continuously for 2 cycles (1 cycle = 4 wks) followed by 20 mg QW. Up to 2 dose reductions will be allowed. Pts will receive obinutuzumab 1000 mg IV (cycle 1: days 1, 8, and 15; cycles 2–6: day 1) and bendamustine 90 mg/m2 IV (cycles 1–6: days 1 and 2). In part 2 (expansion), the safety and efficacy of INCB050465 (maximum tolerated dose) plus obinutuzumab and bendamustine will be evaluated in 30 pts, including pts treated in part 1 at the dose level deemed safe and tolerated. In both parts 1 and 2, pts not progressing after 6 cycles will be maintained on INCB050465 at the dose deemed safe and tolerated, and will continue on obinutuzumab 1000 mg IV administered on Day 1 of every second cycle for an additional 24 cycles or until disease progression. Response will be assessed using Lugano criteria (FDG-PET; CT/MRI) every 12 wks until cycle 12 and every 16 wks thereafter. The trial is open for enrollment. Clinical trial information: NCT03039114.

A phase ll study of trastuzumab in combination with triweekly S-1 plus CDDP in HER2-positive advanced gastric cancer (HERBIS-1).

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 70-70 ◽  
Author(s):  
Naotoshi Sugimoto ◽  
Junji Tanaka ◽  
Masahiro Tsuda ◽  
Wataru Okamoto ◽  
Hiroyuki Okuda ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Response Rate ◽  
Rapid Progression ◽  
Her2 Positive ◽  
Eligibility Criteria ◽  
Threshold Response ◽  
Esophagogastric Junction Adenocarcinoma ◽  
Ecog Ps ◽  
Measurable Lesion

70 Background: S-1, an oral fluoropyrimidine, plus cisplatin (SP) regimen is one of the standard chemotherapy as first-line for advanced gastric cancer (AGC). Although ToGA study demonstrated that trastuzumab (T-mab) in combination with capecitabine plus cisplatin or fluorouracil plus cisplatin improved the overall survival of patients (pts) with HER2-positive AGC, there was no study evaluating the efficacy and the safety of T-mab in combination with SP regimen. Methods: Eligibility criteria included gastric or esophagogastric junction adenocarcinoma; HER2-positive confirmed by IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive); unresectable or recurrent; measurable lesion; no history of chemotherapy or radiotherapy; age≤75; ECOG PS of 0-1; and adequate organ function. Pts received S-1 at 40–60 mg depending on body surface area, po bid, day 1-14, and cisplatin 60 mg/m2, iv, day 1, plus T-mab 8 mg/ kg, iv, day 1 (6 mg/ kg, iv, d1 from 2nd course), repeated every 3 weeks until disease progression. Primary endpoint was response rate assessed by the RECIST (ver 1.1). The planned sample size was 50 based on the threshold response rate of 35%, the expected rate of 50%, power of 80%, and 1-sided α of 0.1. Results: A total of 56 pts were enrolled from July 2011 to May 2012. Two pts were ineligible with inadequate renal function and no measurable lesion. Characteristics of 54 eligible pts were as follows: median age of 66 (range 34-75), M/F: 42/12, PS0/1: 42/12, unresectable/recuurent: 51/3, and IHC 2+/3+: 9/45. As one patient did not receive the protocol treatment due to the rapid progression of tumor, the efficacy and the safety analyses were conducted in the full analysis set of 53 pts. The confirmed response rate assessed by the independent review committee was 68%, and the disease control rate was 94%. The response rate without interval confirmation was 75%. The grade 3/4 adverse events (>5% of pts) were as follows: neutropenia 30%, leucopenia 8%, anorexia 21%, diarrhea 8%, hypoalbuminemia 8%, vomiting 6%, and increased creatinine 6%. Conclusions: T-mab in combination with triweekly SP regimen showed promising antitumor activity and manageable toxicities in pts with HER2-positiveAGC. Clinical trial information: UMIN000005739.

Phase II study of docetaxel plus epirubicin versus docetaxel plus cisplatin as first-line chemotherapy for treatment of advanced breast cancer (CHN TAX-618)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10535-10535
Author(s):  
Y. J. Wang ◽  
Q. Fu ◽  
Q. Wu ◽  
F. X. Su ◽  
L. Z. Zhou ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Response ◽  
Significant Activity ◽  
First Line ◽  
Advance Breast Cancer ◽  
Significant Difference ◽  
Grade 3 ◽  
To Receive ◽  
Measurable Lesion ◽  
Line Chemotherapy

10535 Background: The combination of docetaxel plus epirubicin (TE) have demonstrated a significant activity in advance breast cancer (ABC) as first-line chemotherapy. In the meantime, some emerging literatures suggest that docetaxel-cisplatin (TP) combination has a powerful synergistic interaction with less cardiotoxicity. The main objectives of this multicenter study are to evaluate the efficacy and safety of TE versus TP. Methods: From August 2003 to February 2005, 80 patients with at least one measurable lesion were randomized with ratio of 2:1 to receive TE or TP as as first-line chemotherapy. Dosages were as follows: docetaxel 75 mg/m2 plus epirubicin 60 mg/m2 or docetaxel 75 mg/m2 plus cisplatin 75 mg/m2 intravenously once every 3 weeks for a maximum of 6 cycles. Baseline characteristics were well balanced. Results: A total of 55 patients were assigned to TE (median age 48 yearas) and 25 patients were treated with TP (median age 50 yearas). The same of median 4 cycles treatment were administered for two arms. A complete clinical response was observed in 3.6% and 4.0% of patients treated with TE and TP, respectively (P = 1.00). Overall (complete and partial) clinical response rates for TE and TP were 48% and 56%, respectively (P =0.469). Disease control rates (CR + PR + SD) for TE and TP were 83.6% and 80%, respectively (P = 0.755). The median TTP were TE: 10.8months,TP: 11.2 months days (P = 0.247). Grade 3/4 toxicities included: nausea/vomiting (16.3% TE; 12.0% TP); diarrhea (1.8% TE; 0% TP); alopecia (32.7% TE; 12.0% TP); anemia (1.8% TE; 4.0%TP); neutropenia (65.5% TE; 4.8% TP); febrile neutropenia (3.6% TE; 0% TP). Conclusions: Both TE and TP were active and tolerant regimens for ABC. While there may have been a trend toward lower toxicities in favor of the docetaxel/cisplatin combination, although no significant difference was observed during our study. No significant financial relationships to disclose.

A phase II study of combination chemotherapy with gemcitabine, 5-fluorouracil, and cisplatin (GFP) for advanced pancreatic cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14066-14066
Author(s):  
S. R. Kim ◽  
S. B. Choi ◽  
Y. J. Yuh
Keyword(s):  
Pancreatic Cancer ◽  
Combination Chemotherapy ◽  
Advanced Pancreatic Cancer ◽  
Phase Iii ◽  
Standard Regimen ◽  
Who Grade ◽  
Phase Iii Trial ◽  
Clinical Benefit Response ◽  
Grade 3 ◽  
Measurable Lesion

14066 Background: Gemcitabine has been the standard regimen for advanced pancreatic cancer, but the effect on the response rate and survival is still disappointing. 5-fluorouracil(5-FU) and cisplatin are synergistic with gemcitabine as well as with each other. This study is aimed to determine the efficacy and safety of combination chemotherapy with gemcitabine, 5-FU and cisplatin for advanced pancreatic cancer. Methods: Patients(pt) with recurred or advanced pancreatic cancer were entered into this study, who had histologically proven adenocarcinoma, no prior radiotherapy, measurable lesion (≥2cm), ECOG performance scale (PS) 0–2, age 18–70, adequate bone marrow, cardiac and renal function, ALT ≤ 3× normal, and total bilirubin ≤ 2mg/dL.The pt were treated every 3weeks with gemcitabine 800 mg/m2, at 10mg/m2/min on days 1 and 8, 5-FU 1g/m2/24 hour continuous infusion from day 1 through 3 for 72 hours (extended to 4 days later in 12 pt due to lack of toxicity), and cisplatin 60 mg/m2 on day 2, 24 hours after the start of gemcitabine. Concurrent chemo-radiotherapy with gemcitabine 250 mg/m2/week was given to the pt with response of stable disease or better after 4 cycles of chemotherapy, if PS ≤1 and age ≤ 65. Results: Characteristics of 25 eligible pt; 17 male/ 8 female, PS 0,1 in 20 pt, 2 in 4 pt, Stage III in 3 pt, IV in 22, age 40–69 (median 62). Five pt had prior 5-FU-based chemotherapy. A total of 109 cycles were given (median 4; 1–10 cycles/person). Response by WHO criteria: 3 PR (14.3%; 95% confidence interval: 0 - 29.6%), 11 SD (52.4%) and 7 PD in 21 assessable pt. The median time to progression was 230 days (48+-478+) and median survival was 322 days (70+-757+). WHO grade ≥3 toxicity: neutropenia 19.3% (/cycle), thrombocytopenia 28.4%, mucositis 1.8%, and nausea and vomiting 5.6%. The clinical benefit response and correlation of tumor response with CA-19–9 level will be detailed on presentation. Conclusions: The chemotherapy with gemcitabine, 5-FU and cisplatin for advanced pancreatic cancer is safe, active and may have better survival benefit than gemcitabine alone. Based on these results, a nationwide phase III trial comparing with gemcitabine alone has been started. No significant financial relationships to disclose.

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