A phase-II study evaluatin safety and efficacy with weekly paclitaxel and carboplatin as a primary treatment for patients with advanced epithelial ovarian cancer (EOC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5077-5077 ◽  
Author(s):  
T. Safra ◽  
R. Bernstein Molho ◽  
D. Grisaru ◽  
S. Spigel ◽  
R. Geva ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Epithelial Ovarian Cancer ◽  
Median Time ◽  
Phase Ii ◽  
Complete Response ◽  
Disease Recurrence ◽  
Primary Treatment ◽  
Safety And Efficacy ◽  
Grade 3

5077 Background: The standard chemotherapy for epithelial ovarian cancer (EOC) is carboplatin and paclitaxel every 3 weeks together with debulking surgery. This phase II trial was designed to determine the safety and efficacy of weekly carboplatin and paclitaxel treatment in patients with EOC. Methods: Between October 2003 to August 2005, 37 patients with stage Ic-IV epithelial ovarian, tubal or primary peritoneal carcinoma were enrolled into the study. Carboplatin at AUC=2 and paclitaxel at 80 mg/m2 were administered on days 1,8,15 of a 28-day cycle. Cytoreductive surgery was performed as primary treatment or after 3 cycles of neoadjuvant chemotherapy with additional chemotherapy after the surgery. Results: Median age of the patients was 67 (range 49–82). A mean of 6 chemotherapy cycles were administered (range 3–8). Median time of follow-up (from the beginning of chemotherapy until the last follow-up visit) was 15.57 months (range 0.2–26months). Thirty-three patients were evaluable for response. Complete response (CR) was observed in 26 patients (78.8%) and partial response (PR) in 7 (21.8%). By the time of data collection 13 out of 33 women (39.4%) experienced recurrent or persistent disease and one patient (3%) died from progressive disease during 2nd line chemotherapy. Since 20 out of 33 patients are still free of disease and all but one are still alive, it is too early to evaluate time to progression (TTP) and overall survival (OS). The median time to disease recurrence or progression after completion of primary chemotherapy was 7.5+ months (0.2–18.2+). As for toxicity; grade 3 and 4 neutropenia were seen in 5 (13.5%) and one patient (2.7%) respectively. There was no neutropenic fever. Other grade 3 and 4 hematologic toxicities were not observed. Six (16.2%) and 5 (13.5%) patients needed G-CSF and Epoetin support respectively. The main non-hematologic toxicities were alopecia (grade 1) and fatigue (grade 3 in two patients). Only two patients (5.4%) experienced grade 3 neuropathy. Conclusion: Weekly treatment with carboplatin and paclitaxel is feasible and well tolerated. The low toxicity rate especially regarding neuropathy warrants further investigation of this regimen. No significant financial relationships to disclose.

Risk of Epithelial Ovarian Cancer Recurrence in Patients With Rising Serum CA-125 Levels Within the Normal Range

2005 ◽  
Vol 23 (36) ◽  
pp. 9338-9343 ◽  
Author(s):  
Antonio Santillan ◽  
Ruchi Garg ◽  
Marianna L. Zahurak ◽  
Ginger J. Gardner ◽  
Robert L. Giuntoli ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Epithelial Ovarian Cancer ◽  
Elevated Serum ◽  
Complete Response ◽  
Disease Recurrence ◽  
Ca 125 ◽  
Cancer Antigen 125 ◽  
Normal Range ◽  
Absolute Increase

PurposeTo evaluate the risk of epithelial ovarian cancer (EOC) recurrence in patients with rising serum cancer antigen 125 (CA-125) levels that remain below the upper limit of normal (< 35 U/mL).Patients and MethodsAll patients treated for EOC between September 1997 and March 2003 were identified and screened retrospectively for the following: (1) elevated serum CA-125 at time of diagnosis, (2) complete clinical and radiographic response (CR) to initial treatment with normalization of serum CA-125, (3) at least three serial serum CA-125 determinations that remained within the normal range, and (4) clinical and/or radiographic determination of disease status at the time of last follow-up or recurrence. For statistical analyses, univariate regression models were used to compare absolute and relative changes in CA-125 levels among patients with recurrent disease and those without EOC recurrence.ResultsA total of 39 patients satisfied study inclusion criteria; 22 patients manifested EOC recurrence at a median interval from complete response of 11 months. The median follow-up time from complete response to last contact was 32 months for the 17 patients in the no recurrence group. A relative increase in CA-125 of 100% (odds ratio [OR] = 23.7; 95% CI, 2.9 to 192.5; P = .003) was significantly predictive of recurrence. From baseline CA-125 nadir levels, an absolute increase in CA-125 of 5 U/mL (OR = 8.4; 95% CI, 2.2 to 32.6; P = .002) and 10 U/mL (OR = 71.2; 95% CI, 4.8 to > 999.9; P = .002) were also significantly associated with the likelihood of concurrent disease recurrence.ConclusionAmong patients with EOC in complete clinical remission, a progressive low-level increase in serum CA-125 levels is strongly predictive of disease recurrence.

Phase II consolidation trial with anti-Lewis-Y monoclonal antibody (hu3S193) in platinum-sensitive ovarian cancer after a second remission

2021 ◽  
pp. ijgc-2020-002239
Author(s):  
Oren Smaletz ◽  
Gustavo Ismael ◽  
Maria Del Pilar Estevez-Diz ◽  
Ivana L O Nascimento ◽  
Ana Luiza Gomes de Morais ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Monoclonal Antibody ◽  
Epithelial Ovarian Cancer ◽  
Phase Ii ◽  
Progression Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Platinum Sensitive ◽  
Platinum Based Chemotherapy ◽  
Lewis Y

ObjectiveTo investigate the efficacy and safety of hu3S193, a humanized anti-Lewis-Y monoclonal antibody, as a consolidation strategy in patients with platinum-sensitive recurrent epithelial ovarian cancer who achieved a second complete response after salvage platinum-doublet chemotherapy.MethodsThis single-arm phase II study accrued patients with recurrent epithelial ovarian cancer with Lewis-Y expression by immunohistochemistry who had achieved a second complete response after five to eight cycles of platinum-based chemotherapy. Patients received intravenous infusions of hu3S193, 30 mg/m2 every 2 weeks starting no more than 8 weeks after the last dose of chemotherapy and continuing for 12 doses, until disease progression, or unacceptable toxicity. The primary endpoint was progression-free survival of the second remission. Secondary objectives were safety and pharmacokinetics.ResultsTwenty-nine patients were enrolled. Most had a papillary/serous histology tumor (94%), stage III disease at diagnosis (75%), and five (17%) underwent secondary cytoreduction before salvage chemotherapy. Two patients were not eligible for efficacy but were considered for toxicity analysis. Eighteen patients (62%) completed the full consolidation treatment while nine patients progressed on treatment. At the time of analysis, 23 patients (85%) of the eligible population had progressed and seven of these patients (26%) had died. Median progression-free survival of the second remission was 12.1 months (95% CI: 10.6–13.9), with a 1-year progression-free survival of the second remission rate of 50.1%. The trial was terminated early since it was unlikely that the primary objective would be achieved. The most commonly reported treatment-related adverse events were nausea (55%) and vomiting (51%).ConclusionsHu3S193 did not show sufficient clinical activity as consolidation therapy in patients with recurrent epithelial ovarian cancer who achieved a second complete response after platinum-based chemotherapy.Trial registrationNCT01137071.

scholarly journals Follow-up of patients who are clinically disease-free after primary treatment for fallopian tube, primary peritoneal, or epithelial ovarian cancer: a Program in Evidence-Based Care guideline adaptation

2016 ◽  
Vol 23 (5) ◽  
pp. 343 ◽  
Author(s):  
T. Le ◽  
E.B. Kennedy ◽  
J. Dodge ◽  
L. Elit
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Epithelial Ovarian Cancer ◽  
Fallopian Tube ◽  
Controlled Trial ◽  
Elevated Serum ◽  
Primary Treatment ◽  
Evidence Based ◽  
Guidance Document

Background A need for follow-up recommendations for survivors of fallopian tube, primary peritoneal, or epithelial ovarian cancer after completion of primary treatment was identified by Cancer Care Ontario’s Program in Evidence-Based Care.Methods We searched for existing guidelines, conducted a systematic review (medline, embase, and cdsr, January 2010 to March 2015), created draft recommendations, and completed a comprehensive review process. Outcomes included overall survival, quality of life, and patient preferences.Results The Cancer Australia guidance document Follow Up of Women with Epithelial Ovarian Cancer was adapted for the Ontario context. A key randomized controlled trial found that the overall survival rate did not differ between asymptomatic women who received early treatment based on elevated serum cancer antigen 125 (ca125) alone and women who waited for the appearance of clinical symptoms before initiating treatment (hazard ratio: 0.98; 95% confidence interval: 0.80 to 1.20; p = 0.85); in addition, patients in the delayed treatment group reported good global health scores for longer. No randomized studies were found for other types of follow-up. We recommend that survivors be made aware of the potential harms and benefits of surveillance, including a discussion of the limitations of ca125 testing. Women could be offered the option of no formal follow-up or a follow-up schedule that is agreed upon by the woman and her health care provider. Education about the most common symptoms of recurrence should be provided. Alternative models of care such as nurse-led or telephone-based follow-up (or both) could be emerging options.Conclusions The recommendations provided in this guidance document have a limited evidence base. Recommendations should be updated as further information becomes available.

A Phase II Study of Intravenous Azacitidine Alone in Patients with Myelodysplastic Syndromes NCT00384956.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1451-1451
Author(s):  
Richard Walgren ◽  
Crystal Dao ◽  
Frederieke Kreisel ◽  
Peter Westervelt ◽  
Camille Abboud ◽  
...  
Keyword(s):  
Median Time ◽  
Phase Ii ◽  
De Novo ◽  
Phase Ii Study ◽  
Study Drug ◽  
Complete Response ◽  
Subsequent Treatment ◽  
Open Label ◽  
Erythroid Response

Abstract Rationale: 5-Azacytidine (Aza), a DNA hypomethylating agent, has now been shown in 2 clinical trials involving high-risk MDS patients to provide a survival benefit over supportive/conventional care regimens. While one phase II study used a continuous 7-day IV infusion, Aza was administered subcutaneously (SQ) in most pre-approval studies. However, injection site reactions are not uncommon with SQ dosing, especially in thrombocytopenic patients. Aza given as a short intravenous (IV) infusion is anticipated to be efficacious from pharmacokinetic profiling and is FDA approved, but prospective efficacy data for short IV infusion are lacking. Study aim and design: To determine the efficacy of IV Aza when given as a short infusion, we have undertaken an open-label, single-arm, single-center phase II study of Aza in patients with MDS, either de novo or secondary, defined by FAB classification. Previously treated subjects were ineligible if they had already received Aza or decitabine. Treatment consisted of Aza 75 mg/m2 given as a 20 minute IV infusion once daily on Days 1–5 of a 28-day cycle. Response was evaluated by IWG 2000 criteria. After two cycles at the 75 mg/m2 dose, patients failing to achieve a CR were eligible for an increased dose of 100 mg/m2. After 6 cycles of therapy, patients must have demonstrated at least a hematologic improvement to continue on study. Study endpoints include determination of the complete response (CR) and partial response (PR) rates, and secondary endpoints examined the rates of hematological improvement, time to progression, and cytogenetic response. Results: Accrual began 8/17/06 with a target of 21 subjects. As of 7/31/07, 15 subjects have accrued with a median follow-up of 77 days (range 4 to 246). Subjects consisted of 9 males and 6 females with a median age of 69.6 yr (range 53 to 82). The median time from diagnosis is 213 days (range 0 days to 4 yr). By FAB criteria, subjects consist of 4 RA, 9 RAEB, 1 RAEB-t, and 1 CMML, and subjects are categorized by IPSS risk as 1 Low, 4 Int-1, and 10 Int-2. Two patients had therapy related MDS. The data remain preliminary with subjects having completed a mean of 3 cycles (range 1 to 6). None of the 5 subjects who have completed at least 4 cycles of therapy have achieved a CR. However, 2 (40%) of these subjects achieved a PR. Additionally, 1 (20%) patient had a major erythroid response, while another had a minor erythroid response. Median time to response was 2 months. Ten subjects remain on study, 1 patient withdrew due to progressive disease (in first week of therapy), and 4 deaths have occurred on study (2 due to sepsis, 1 each due to pneumonia and acute MI). No deaths were attributed to study drug. Common adverse events include nausea, emesis, and hematologic toxicities. Grade 2–3 nausea and grade 2–3 emesis each occurred in 5 subjects. Observed grade 3 or 4 hematologic toxicities included: anemia (n=7), thrombocytopenia (n=4), leukopenia (n=3), neutropenia (n=7), and febrile neutropenia (n=1). Hematologic toxicities have resulted in transient treatment delays (&lt; 4 weeks) and dose reduction, but hematologic toxicities have not prevented subsequent treatment on study. Conclusions: Although follow-up is short for assessment of efficacy, this is the first prospective study to report on efficacy and toxicity of short infusional Aza in the treatment of MDS.

The VcR-CVAD Regimen Produces a High Complete Response Rate in Untreated Mantle Cell Lymphoma (MCL): First Analysis of E1405 – A Phase II Study of VcR-CVAD with Maintenance Rituximab for MCL.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1661-1661 ◽  
Author(s):  
Brad S Kahl ◽  
Hailun Li ◽  
Mitchell R Smith ◽  
Randy D. Gascoyne ◽  
Elisabeth Paietta ◽  
...  
Keyword(s):  
Phase Ii ◽  
Research Funding ◽  
Response Rate ◽  
Complete Response Rate ◽  
Phase Ii Study ◽  
Cell Lymphoma ◽  
Complete Response ◽  
Mantle Cell ◽  
Grade 3

Abstract Abstract 1661 Poster Board I-687 Introduction One approach to improving outcomes in Mantle Cell Lymphoma (MCL) is to incorporate newer targeted agents into standard chemotherapy regimens. As the proteasome inhibitor bortezomib (Velcade‘) achieved a 33% response rate in relapsed MCL, we hypothesized that the incorporation of Velcade (Vc) into a modified R-hyperCVAD chemotherapy backbone would result in a high complete response rate (CR). The new regimen, VcR-CVAD, was tested for safety and efficacy in a phase II study within the Wisconsin Oncology Network (UW) and demonstrated a CR rate of 77% (Kahl, ASH 2008). To determine the safety and efficacy of this regimen in a cooperative group setting, we initiated E1405: a phase II study of VcR-CVAD with maintenance rituximab (MR) for untreated MCL. Methods Eligible patients had histologically confirmed, previously untreated MCL, PS 0-2, and adequate end organ function. The treatment plan included: Velcade 1.3 mg/m2 days 1 and 4, rituximab 375 mg/m2 IV day 1, cyclophosphamide 300 mg/m2 IV over 3 hrs q 12 hrs X 6 doses days 1-3, doxorubicin 50 mg/m2 continuous infusion over 48 hrs days 1-2, vincristine 1 mg IV day 3, dexamethasone 40 mg po days 1-4. Cycles were repeated every 21 days for 6 cycles and all patients received G-CSF support. Patients achieving SD, PR, or CR received MR administered as 4 weekly treatments every 6 months for 2 years (protocol therapy). Patients had an option to receive high dose chemotherapy and autologous stem cell transplantation (off protocol) rather than MR. The primary endpoint of the trial was the CR rate, incorporating PET imaging, to VcR-CVAD induction therapy. Results Seventy-six eligible patients were enrolled between 5/07 and 10/08. Baseline characteristics include median age 62 (40-76), 59M:17F, 91% stage III/IV, and 39% with elevated LDH. Sixty-four patients (84%) completed VcR-CVAD induction therapy. Reasons for treatment discontinuation included PD (1), toxicity (4), patient preference (2), and other/unknown (5). Response information is available on 74 patients while data is outstanding on 2 patients. The ORR was 96% (73/76; 95% CI, 89%-99%), CR rate 75% (57/76; 95% CI, 64%-84%) and the PR rate 21% (16/76; 95% CI, 13%-32%). Six of the PR patients were coded as such because of protocol violations in which a post-treatment bone marrow biopsy or PET scan was not obtained. The CR rate in the 68 completely restaged patients was 84%. Forty-four patients proceeded to planned MR while 21 patients went off protocol to SCT consolidation. Median follow up is currently too short (9 months) to assess PFS and OS. The major toxicity of the treatment regimen was expected myelosuppression. Grade 3-4 non hematologic toxicities were rare. No patients developed grade 3-4 neuropathy. There were no treatment related deaths. Conclusion The VcR-CVAD induction produced high overall response (96%) and CR rate (75%) in a representative MCL patient population treated on a cooperative group protocol. The CR rate was high and comparable to the UW pilot study (77%). No episodes of severe painful peripheral neuropathy were reported using the reduced vincristine dosage and the overall toxicity profile was very acceptable. Longer follow up is needed to determine if the high CR rate will translate into improved PFS and OS. Disclosures Kahl: Genentech: Consultancy, Research Funding; Millennium: Consultancy, Research Funding. Off Label Use: Bortezomib as front line treatment in MCL. Smith:Genentech: Research Funding; Millennium: Research Funding. Advani:Seattle Genetics, Inc.: Research Funding. Horning:Genentech: Honoraria, Research Funding.

The relevance of rising CA-125 levels within the normal range in predicting recurrence in patients with advanced stage ovarian cancer: A validation study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16521-e16521
Author(s):  
F. AbuShain ◽  
P. Escobar ◽  
S. Shahabi ◽  
C. Michener ◽  
R. Drake ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Stage Iv ◽  
Complete Response ◽  
Disease Recurrence ◽  
Ca 125 ◽  
Normal Range ◽  
Number Of Patients ◽  
Response To Chemotherapy ◽  
Significant Difference

e16521 Background: Small published series suggested that three progressively rising CA-125 values, doubling of CA-125, and an absolute rise of 5 U/mL from the nadir, all while remaining in the normal range were highly associated with disease recurrence. This study aims to validate these proposed criteria in a larger population. Methods: We conducted a retrospective review of the records of patients with stages IIIC and IV epithelial ovarian cancer treated with primary surgery and adjuvant chemotherapy between 1994 and 2006. Only patients who had a complete response to chemotherapy verified by normal CT scan, CA-125 and physical examination were included. Nadir CA-125 level was defined as the first CA-125 measurement after completing chemotherapy. Available CA-125 values from diagnosis to recurrence or to last follow up were collected and evaluated for meeting any of the criteria above. Results: 91 patients with a median age of 59 (42 - 88) met the inclusion criteria. 82 patients had stage IIIC (90%) and 9 patients (10%) had stage IV. 86 patients (94.5%) had papillary serous histology and 88 patients had grade 3 (96.7%) disease. Median follow up was 43.7 months (12.6 - 156). Table 1 shows the number of patients who met any of the above CA-125 criteria in total and divided by the presence or absence of recurrence. There was no statistically significant difference in meeting any of the CA-125 criteria between the recurrence and no recurrence groups. Meeting at least one of the CA-125 criteria had 50% sensitivity, 65% specificity, and 86% positive predictive value for recurrence. The median time to recurrence in patients who met at least one CA-125 criteria was 3.8 months (0.2 - 12.4) and the median follow up time after meeting one of the CA 125 criteria in patients who did not recur was 88.5 months (10.4 - 188) Conclusions: Rising CA-125 levels within the normal range that meet any of the above criteria are highly predictive (86%) of recurrence within 12 months and closer observation is warranted. [Table: see text] No significant financial relationships to disclose.

Practice patterns in post-treatment surveillance in patients with primary epithelial ovarian cancer

2020 ◽  
pp. ijgc-2020-001522
Author(s):  
Joseph DeMari ◽  
Monica Hagan Vetter ◽  
Shruthi Chandra ◽  
John L Hays ◽  
Ritu Salani
Keyword(s):  
Ovarian Cancer ◽  
Epithelial Ovarian Cancer ◽  
Practice Patterns ◽  
Early Stage ◽  
Gynecologic Oncology ◽  
Complete Response ◽  
Response To Therapy ◽  
Primary Therapy ◽  
Advanced Stage

BackgroundThe Society of Gynecologic Oncology created guidelines to standardize cost-effective clinical surveillance for detection of recurrence of gynecologic cancers.ObjectiveTo determine practice patterns for surveillance of primary ovarian cancer after complete response to therapy and to identify the percentage of clinicians who follow the surveillance guidelines endorsed by the Society of Gynecologic Oncology.MethodsA single-institution retrospective cohort study was conducted including patients with epithelial ovarian cancer with a complete response to primary therapy between January 2012 and December 2016. Patients were excluded if they were participating in clinical trials that required routine imaging. Data on surveillance and recurrence were collected. Descriptive statistics as well as Fisher’s exact test and chi-square test were performed due to the exploratory nature of the study.ResultsA total of 184 patients met the inclusion criteria. Median follow-up for the cohort was 37 months (range 6–80). Surveillance was completed in compliance with Society of Gynecologic Oncology guidelines in 78% of patients. Of 39 visits that were non-compliant, 44% (17) were patient initiated (scheduling conflict, missed appointment), 15% (6) were due to the provider intentionally scheduling alternative follow-up, while 41% (16) were off schedule due to problem visits (patient complaint of symptoms). Patients with early-stage cancers were more likely than advanced-stage patients to be non-compliant (33% vs 15%, p=0.006). Patients with non-serous histologies had a higher frequency of non-compliance (31% vs 16%, p=0.035). When stratified by early versus advanced stage, there was no difference in progression-free survival or overall survival based on compliance.ConclusionsOverall, there was a relatively high rate of compliance with Society of Gynecologic Oncology surveillance guidelines for patients with epithelial ovarian cancer. Patients with non-serous histologies and patients with early-stage disease had a higher rate of non-compliance, and these patients may represent special groups that would benefit from additional survivorship education.

Lenvatinib plus pembrolizumab combination therapy in patients with radioiodine-refractory (RAIR), progressive differentiated thyroid cancer (DTC): Results of a multicenter phase II international thyroid oncology group trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6512-6512 ◽  
Author(s):  
Bryan Haugen ◽  
Jena French ◽  
Francis P. Worden ◽  
Bhavana Konda ◽  
Eric Jeffrey Sherman ◽  
...  
Keyword(s):  
Adverse Events ◽  
Median Time ◽  
Phase Ii ◽  
Evaluation Criteria ◽  
Progression Free Survival ◽  
Complete Response ◽  
Maculopapular Rash ◽  
Multicenter Phase ◽  
Secondary Endpoints ◽  
Grade 3

6512 Background: Lenvatinib is an approved therapy for patients with RAIR DTC. While the overall response rate (ORR) is high, few patients achieve a complete response (CR) and most patients eventually have progressive disease (PD). Combination lenvatinib and pembrolizumab is being explored in many different cancers, and this combination has been approved for advanced endometrial carcinoma. Methods: Patients with RAIR DTC with Response Evaluation Criteria in Solid Tumor (RECIST v1.1) measurable PD (<14 months (mo) prior to registration) were enrolled in this single-arm multicenter phase II study. Patients were excluded if they had received previous VEGFR-directed multikinase therapy. The lenvatinib starting dose was 20 mg/day orally and pembrolizumab was 200mg IV every 3 weeks. The primary endpoint was CR. ORR, progression-free survival (PFS) and safety graded by Common Terminology Criteria for Adverse Events v4.0 were secondary endpoints. Results: Thirty patients were enrolled. The median age was 62.5 years, and 53% of the patients were women. Seventy percent of patients had grade 3 adverse events (AEs) and 10 percent had grade 4 AEs. There were no treatment-related deaths. The most common > grade 3 AEs were hypertension (47%), weight loss (13%), maculopapular rash (13%), leukopenia (7%), diarrhea (7%) and oral mucositis (7%). Twenty-one patients (70%) required lenvatinib dose reduction. Of 29 evaluable patients, 18 (62%) had a partial response (PR) and 10 (35%) had stable disease (SD). The clinical benefit rate (ORR +SD) was 97%. Median time to tumor nadir was 7.4 mo (1.6-17.8 mo). Median PFS was not yet reached. The PFS at 12 months was 74%. Median time on therapy was 9.9 mo (3.2-18.9 mo). Fourteen patients are continuing therapy (7.6-18.9 mo). Six of these patients (43%) have not yet reached tumor size nadir. Three patients (10%) had > 80% target tumor shrinkage. Conclusions: Lenvatinib plus pembrolizumab is reasonably tolerated in patients with RAIR DTC. To date, there have been no documented complete responses. Combination lenvatinib plus pembrolizumab therapy has a high ORR in patients with RAIR DTC. Continuation of this study will help determine the depth and length of the responses. Clinical trial information: NCT02973997 .

Sign in / Sign up

Export Citation Format

Share Document