Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with Oxaliplatin, Cisplatin, and Doxorubicin in Patients with Peritoneal Carcinomatosis: An Open-Label, Single-Arm, Phase II Clinical Trial

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is an innovative approach for treating peritoneal carcinomatosis that applies chemotherapeutic drugs into the peritoneal cavity as an under-pressure airflow. It improves local bioavailability of cytostatic drugs as compared to conventional intraperitoneal chemotherapy. The aim of this study is to prove feasibility, efficacy and safety of this new treatment. Patients included in the analysis underwent at least two single port PIPAC procedures; drugs used were Oxaliplatin for colorectal cancers and Cisplatin + Doxorubicin for ovarian, gastric, and primary peritoneal cancers. The primary endpoint was the Disease Control Rate according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Secondary significant endpoints were overall and progression free survival, tumor regression on histology, and quality of life. Safety and tolerability were assessed according to the Common Terminology Criteria for Adverse Events 4. Sixty-three patients were enrolled in this trial. Forty patients (100 PIPAC) were eligible for analysis. Twenty patients were undergoing systemic chemotherapy. Fourteen patients reported an objective response (35%). Median overall survival was 18.1 months; median progression-free survival was 7.4 months. Minor morbidity was observed in seven procedures. Grade 3 complications occurred in two patients, and grade 4 in one patient submitted to reoperation. Single-port PIPAC is feasible, safe, and easy to perform. The combined treatment based on systemic chemotherapy and PIPAC does not induce significant hepatic and renal toxicity and can be considered a valid therapeutic option in patients with advanced peritoneal disease. Further studies on the use of PIPAC alone, possibly with different drug dosages, may define the real effectiveness of the procedure.

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PIPAC-OV3: A multicenter, open-label, randomized, two-arm phase III trial of the effect on progression-free survival of cisplatin and doxorubicin as Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) vs. chemotherapy alone in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer

Pleura and Peritoneum ◽

10.1515/pp-2018-0114 ◽

2018 ◽

Vol 3 (3) ◽

Cited By ~ 8

Author(s):

Naoual Bakrin ◽

Clemens Tempfer ◽

Giovanni Scambia ◽

Michele De Simone ◽

Boris Gabriel ◽

...

Keyword(s):

Primary Endpoint ◽

Systemic Chemotherapy ◽

Liposomal Doxorubicin ◽

Tumor Response ◽

Tumor Regression ◽

Pegylated Liposomal Doxorubicin ◽

Progression Free Survival ◽

Phase Iii ◽

Peritoneal Disease ◽

Free Survival

AbstractBackgroundRecurrent, platin-resistant ovarian cancer (rPROC) has a poor survival. Even with the AURELIA trial, which is the best available treatment today, progression-free survival (PFS) is still only 6.7 months from the start of the second-line chemotherapy. Innovative, effective therapies are urgently needed. Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) is a novel drug delivery system for administering drugs into the abdomen. PIPAC with cisplatin and doxorubicin (PIPAC C/D) may be safely used at an intraperitoneal dose of 10.5 mg/m2 and 2.1 mg/m2, respectively. Systemic toxicity of this therapy is low. In a phase II trial with 53 women, 62 % patients had an objective tumor response. Tumor regression on histology was observed in 76 % patients who underwent all three PIPACs. Randomized phase III studies are now required to evaluate the effect of PIPAC C/D compared to other standard treatments (sequential or simultaneous applications with systemic chemotherapy).MethodsThe present phase III study is a prospective, open, randomized, multicentric pivotal trial. A total of 244 patients will be randomly assigned (1:1) to the control (A) or to the experimental (B) group. Group A: Systemic palliative chemotherapy, physician’s best choice (monotherapy consisting of pegylated liposomal doxorubicin or topotecan or gemcitabine or paclitaxel weekly. Bevacizumab can be used in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin). Group B: Intraperitoneal chemotherapy, 3×PIPAC C/D, performed every 6 weeks. Combination with systemic therapy is not allowed. Treatment is continued until disease progression, death, or patient refusal. In case of progression, no recommendation for further therapy is given by protocol. Patients are allowed to receive PIPAC C/D or systemic chemotherapy after study termination. The primary endpoint is PFS (according to RECIST v1.1) or death from any cause. The co-primary endpoint is the health-related quality of life (HRQoL) measured as the global health status (GHS, QLQ-30 of EORTC). Secondary outcomes comprise overall survival, safety (CTCAE 5.0), and tumor response according to peritoneal regression grading score (PRGS).DiscussionWe expect PIPAC C/D to control peritoneal disease and preserve the QoL on this subset of patients.Trial registrationThe EudraCT number 2018-003664-31

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Clinical implications of polymorphisms in UDP-glucuronosyl transferase (UGT) in patients with metastatic colorectal cancer (mCRC) who were treated with oxaliplatin, irinotecan, and S-1.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.4_suppl.503 ◽

2012 ◽

Vol 30 (4_suppl) ◽

pp. 503-503

Author(s):

Sun Young Kim ◽

Mi Song I Jang ◽

Hyun Mi Kim ◽

Ji Yeon Baek ◽

Yong Sang Hong ◽

...

Keyword(s):

Therapeutic Option ◽

Objective Response ◽

Progression Free Survival ◽

Drug Regimen ◽

High Rate ◽

Free Survival ◽

Effective Therapeutic Option ◽

Glucuronosyl Transferase ◽

Intensive Regimen ◽

Selection Of

503 Background: The three-drug regimen with oxaliplatin, irinotecan and fluoropyrimidine is an effective therapeutic option for patients with mCRC, but is associated with high rate of toxicity. Pharmacogenetic profile might be helpful for selection of proper patients for this intensive regimen. Methods: Forty-two patients were enrolled to our phase II trial and were given irinotecan 150mg/m2 plus oxaliplatin 85mg/m2 on D1 and S-1 80mg/m2/day on D1-14 every 21 days as their front-line therapy for mCRC. Genomic DNA was extracted from peripheral blood, where the presence of germline polymorphisms of UGT including UGT1A1*6, UGT1A1*28, UGT1A1*60, UGT1A6*2, and UGT1A7*3 were tested. Results: Patients with UGT1A1*6 allele had a tendency of more frequent grade 2-3 vomiting (p = 0.06) compared to those without UGT1A1*6. The presence of a haplotype containing UGT1A6*2 and UGT1A7*3 was associated with grade 2-3 vomiting (p = 0.014) and grade 2-3 diarrhea (p = 0.063). Higher objective response rate (18/20, 90%) was noted in patients without UGT1A*60 compared to those with UGT1A1*60 (11/22, 50%; p = 0.008). The absence of UGT1A1*60 was also associated with marginally improved progression-free survival (10.3 mo v 7.7 mo, p = 0.081) and overall survival (26.8 mo v 15.1 mo, p= 0.044) compared to the presence of the variant allele. Conclusions: UGT1A1*6 and a haplotype containing UGT1A6*2 and UGT1A7*3 may be associated with irinotecan-related gastrointestinal toxicities. Phenotypic association of UGT1A1*60 and efficacy of the three-drug regimen requires further investigation.

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Efficacy of Regorafenib in Hepatocellular Carcinoma Patients: A Systematic Review and Meta-Analysis

Cancers ◽

10.3390/cancers12010036 ◽

2019 ◽

Vol 12 (1) ◽

pp. 36 ◽

Cited By ~ 5

Author(s):

Antonio Facciorusso ◽

Mohamed A. Abd El Aziz ◽

Rodolfo Sacco

Keyword(s):

Hepatocellular Carcinoma ◽

Overall Survival ◽

Adverse Events ◽

Therapeutic Option ◽

Controlled Trial ◽

Meta Analysis ◽

Objective Response ◽

Progression Free Survival ◽

Sensitivity Analyses ◽

Free Survival

Regorafenib showed promising results as a second-line agent after sorafenib failure in hepatocellular carcinoma patients. The aim of this meta-analysis was to evaluate the efficacy and safety of regorafenib in hepatocarcinoma patients. A computerized bibliographic search was performed on the main databases. The primary outcome was overall survival. Secondary outcomes were progression-free survival, tumor response, and the adverse events rate. Outcomes were pooled through a random-effects model and summary estimates were expressed in terms of median and 95% confidence interval or rates, as appropriate. One randomized-controlled trial and seven non-randomized studies with 809 patients were included. The great majority of recruited patients were in Child-Pugh A and ECOG 0 stage. Median overall survival was 11.08 months (9.46–12.71) and sensitivity analyses confirmed this finding, with a median survival ranging from 10.2 to 13.8 months. Duration of regorafenib therapy was 3.58 months, whereas median progression-free survival was 3.24 months (2.68–3.86). The pooled objective response rate was 10.1% (7.8–12.5%) while the disease control rate was 65.5% (61.3–69.7%) with no evidence of heterogeneity (I2 = 0%; Diarrhea, fatigue, and hand-foot skin reaction were the most frequent adverse events. The current meta-analysis shows that regorafenib represents a valuable and relatively safe therapeutic option in intermediate/advanced hepatocellular carcinomapatients who progress on sorafenib.

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High Response Rate to Cisplatin/Etoposide Regimen in Childhood Low-Grade Glioma

Journal of Clinical Oncology ◽

10.1200/jco.2002.08.087 ◽

2002 ◽

Vol 20 (20) ◽

pp. 4209-4216 ◽

Cited By ~ 124

Author(s):

Maura Massimino ◽

Filippo Spreafico ◽

Graziella Cefalo ◽

Riccardo Riccardi ◽

John David Tesoro-Tess ◽

...

Keyword(s):

Combined Treatment ◽

Objective Response ◽

Progression Free Survival ◽

Neurofibromatosis Type ◽

High Response Rate ◽

Low Grade Glioma ◽

Low Grade ◽

Free Survival

PURPOSE: The aim of this study was to avoid radiotherapy and to induce an objective response in children with low-grade glioma (LGG) using a simple chemotherapy regimen based on cisplatin and etoposide. PATIENTS AND METHODS: Thirty-four children (median age, 45 months) with unresectable LGG were treated with 10 monthly cycles of cisplatin (30 mg/m2/d on days 1 to 3) and etoposide (150 mg/m2/d on days 1 to 3). Tumor originated in the visual pathway in 29 patients, in the temporal lobe in two, in the frontal lobe in two, and in the spine in one. Eight children were affected by neurofibromatosis type 1. Objective tumor response and toxicity were evaluated by magnetic resonance imaging and neurologic and functional tests at 3-month intervals. RESULTS: An objective response was obtained in 24 (70%) of 34 patients, whereas the others had stable disease. None of the children were electively irradiated. In 31 previously untreated children, overall survival was 100% and progression-free survival was 78% at 3 years, with a median follow-up of 44 months. Acute toxicity was unremarkable; 28% patients evaluated for acoustic neurotoxicity revealed a loss of perception of high frequencies. CONCLUSION: Cisplatin and etoposide combined treatment is one of the most active regimens for LGG in children and allows avoidance of radiotherapy in the vast majority of patients.

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Efficacy of EDP ± mitotane chemotherapy in the treatment of metastatic adrenocortical carcinoma. Predictive and prognostic factors of efficacy

Malignant tumours ◽

10.18027/2224-5057-2021-11-1-37-46 ◽

2021 ◽

Vol 11 (1) ◽

pp. 37-46

Author(s):

Ya. A. Zhulikov ◽

E. I. Kovalenko ◽

V. Yu. Bohyan ◽

M. V. Khoroshilov ◽

M. M. Gabrava ◽

...

Keyword(s):

Prognostic Factors ◽

Adrenocortical Carcinoma ◽

Median Overall Survival ◽

Therapeutic Option ◽

Objective Response ◽

Group Versus ◽

Progression Free Survival ◽

Ki 67 ◽

Free Survival ◽

Effective Therapeutic Option

Introduction. Adrenocortical carcinoma (ACC) is an orphan disease with an unfavorable prognosis. The most effective therapeutic option in the treatment of ACC is EDP plus mitotane combination chemotherapy. However, no studies comparing the efficacy of the EDP regimen with or without mitotane have been published.Materials and methods. A retrospective analysis of health records of patients with histologically confirmed metastatic ACC, who received at least one chemotherapy cycle with EDP ± mitotane. The study included 73 patients, 49 of which received a combination of EDP and mitotane and 24 were treated with EDP chemotherapy.Results. The objective response rate was 18,4 % in the EDP + mitotane group versus 4,1 % in the EDP group. Disease control was reported in 25 (51 %) and 13 (54,2 %) patients, respectively. No significant differences were found in progression-free survival (PFS) rates between the EDP and EDP + mitotane groups; the median PFS rate was 6,5 and 6,0 months, respectively. The median overall survival (OS) in the total population was 20,9 months; no significant differences were found between the groups. However, an increase in median PFS was observed in patients who achieved a therapeutic concentration of mitotane. Moreover, the achievement of therapeutic mitotane concentrations was the only factor significantly associated with improved PFS (HR 0.44, p = 0.006). Significant unfavorable prognostic factors associated with lower OS were Ki-67 level in the primary tumor > 20 % (HR 10.5, p = 0.006) and more than 1 site of metastases (HR 3.82, p = 0.02).Conclusions. This study showed that the addition of mitotane to EDP chemotherapy does not improve the median PFS and OS in the total patient population, however, the achievement of therapeutic mitotane concentrations is significantly associated with improved progression-free survival.

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Long-Term Followup of Patients with Follicular Lymphoma (FL) Treated with Two Years of Maintenance Rituximab: Response to Rituximab Retreatment at Progression.

Blood ◽

10.1182/blood.v108.11.4723.4723 ◽

2006 ◽

Vol 108 (11) ◽

pp. 4723-4723 ◽

Cited By ~ 3

Author(s):

John D. Hainsworth ◽

Christina Meng ◽

David R. Spigel ◽

Eric L. Raefsky ◽

John H. Barton ◽

...

Keyword(s):

Stable Disease ◽

Therapeutic Option ◽

Single Agent ◽

Objective Response ◽

Progression Free Survival ◽

Free Survival ◽

Rituximab Maintenance ◽

Aggressive Histology ◽

Maintenance Schedules

Abstract Background: Maintenance treatment with rituximab prolongs progression-free survival (PFS) in patients with FL when administered following single agent rituximab, chemotherapy, or rituximab/chemotherapy combinations. However, the possible induction of lymphoma resistance by prolonged rituximab treatment has been a cause for concern. To address this issue, we obtained long-term followup on patients who had received 2 years of maintenance rituximab and had objective response or stable disease when treatment was discontinued. With a median followup of 7 years, we evaluated the subsequent course of these patients, with particular attention to: treatment administered at relapse, sensitivity to retreatment with rituximab at progression, and survival. Methods: Between March 1998 and August 2002, we treated a total of 106 patients in 2 sequential studies with single-agent rituximab, followed by rituximab maintenance therapy (repeated 4-week courses every 6 months for 2 years). In both studies (JCO20:4261, 2002; JCO23:1088JCO23:2005), rituximab maintenance was arbitrarily discontinued after 2 years. Fifty-eight of 106 patients (55%) in these 2 trials had objective response or stable disease following completion of 2 years of maintenance rituximab. Followup regarding the subsequent course and treatment was obtained in all 58 patients. Results: Nineteen of 58 patients (33%; 18% of all 106 patients treated) remain in continuous remission after a median followup of 7 years (range 4–8 years). Thirty-five patients progressed, while 4 patients died of intercurrent illnesses while in remission. Of the 35 patients who progressed, 24 patients received single-agent rituximab as the next therapy, while 2 patients received rituximab in combination with chemotherapy. Eight of 24 patients (33%) had objective responses to single-agent rituximab (CR 5, PR 3), 14 patients (58%) had stable disease, and 2 patients progressed. Six of the responding patients again received maintenance rituximab. Median PFS in the 22 responding/stable patients was 47 months (95% CI = 39–52 months) with 27% of patients progression-free at 5 years. Both patients receiving rituximab plus chemotherapy had complete remissions (durations 33, 64 months). Transformation to a more aggressive histology was not documented in any patient. The median survival of all 35 relapsing patients, measured from the time of relapse, is 63 months, (95% CI = 40-N.R.). Conclusions: The majority of patients who relapse after 2 years of maintenance rituximab therapy remain sensitive to rituximab. Retreatment with rituximab, either as a single agent or in combination with chemotherapy, is a reasonable therapeutic option at the time of progression. Further investigation of more prolonged rituximab maintenance schedules is indicated.

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Association Between Time to Stent Dysfunction and the Anti-Tumour Effect of Systemic Chemotherapy Following Stent Placement in Patients With Pancreaticobiliary Cancers and Malignant Gastric Outlet Obstruction: A Retrospective Cohort Study

10.21203/rs.3.rs-199477/v1 ◽

2021 ◽

Author(s):

Satoshi Kobayashi ◽

Makoto Ueno ◽

Shuhei Nagashima ◽

Yusuke Sano ◽

Kuniyuki Kawano ◽

...

Keyword(s):

Systemic Chemotherapy ◽

Response Rate ◽

Objective Response ◽

Outlet Obstruction ◽

Progression Free Survival ◽

P Value ◽

Free Survival ◽

Malignant Gastric Outlet Obstruction ◽

Pancreaticobiliary Cancer ◽

Anti Tumour Effect

Abstract Background: Malignant gastric outlet obstruction (mGOO) occasionally occurs due to pancreaticobiliary cancer. Endoscopic duodenal stenting (DS) is a common treatment for MGOO. However, it has been reported that DS does not have a sufficient time to stent dysfunction for it to be used in patients who have a greater potential lifespan. Nowadays, systemic chemotherapy for pancreaticobiliary cancer has developed, and its anti-tumour effect would make time to stent dysfunction longer. We therefore retrospectively evaluated the association between objective response to systemic chemotherapy followed by DS and time to stent dysfunction in patients with advanced pancreaticobiliary cancer. Methods: This retrospective study included 109 patients with advanced pancreaticobiliary cancer who received systemic chemotherapy after DS. Patients who showed complete or partial response were defined as responders. The rest were defined as non-responders. Time to stent dysfunction was compared between responders and non-responders using the landmark analysis, at 2 months after DS. Death without recurrence of MGOO was considered as a censored case for time to stent dysfunction. Results: The combination and monotherapy regimens were adopted for 41 and 68 patients, respectively. Median progression-free survival and overall survival were 3.2 4 months (95% confidence interval [CI], 2.4-4.0) and 6.0 months (95% CI, 4.6-7.3). Objective response was observed in 21 patients (19.3%). Patients who received combination regimens had longer progression-free survival and higher response rate than those with monotherapy regimens; progression-free survival was 5.1 months (95% CI, 3.1-7.0) and 2.6 months (95% CI, 1.6-3.5) with a p-value of <0.001, and response rate was 39.0% and 7.4% with a p-value <0.001, respectively. Median time to stent dysfunction was 12.5 months (95% CI, 8.4-16.5) in the entire cohort. In 89 patients, responders had longer time to stent dysfunction than non-responders: 17.4 months (95% CI, 17.3-17.5) and 7.1 months (95% CI, 1.6-12.5) with a p-value of 0.031. Conclusion: Longer time to stent dysfunction is expected when systemic chemotherapy following DS suppresses tumour progression. DS is slated to be a standard treatment for MGOO, even in patients with pancreaticobiliary cancer and a long lifespan.

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CTIM-03. PHASE II STUDY OF REGORAFENIB IN BEVACIZUMAB REFRACTORY RECURRENT GLIOBLASTOMA

Neuro-Oncology ◽

10.1093/neuonc/noaa215.137 ◽

2020 ◽

Vol 22 (Supplement_2) ◽

pp. ii33-ii33

Author(s):

Yasmeen Rauf ◽

Cathy Schilero ◽

David Peereboom ◽

Manmeet Ahluwalia

Keyword(s):

Dose Escalation ◽

Therapeutic Option ◽

Objective Response ◽

Progression Free Survival ◽

Recurrent Glioblastoma ◽

Weekly Dose ◽

Cellular Functions ◽

Molecule Inhibitor ◽

Secondary Endpoints ◽

Magnetic Resonance Imaging Mri

Abstract BACKGROUND Most patients with glioblastoma (GBM) receive bevacizumab as part of their treatment. There is no good therapeutic option after bevacizumab failure. Regorafenib has potent preclinical antitumor activity and long-lasting anti-angiogenic activity as measured by dynamic contrast enhanced (DCE) – magnetic resonance imaging (MRI). Regorafenib is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment. METHODS Patients with progression of GBM after treatment with Bevacizumab will be eligible for the study. Oral administration of Regorafenib at 160 mg once daily will be administered for 3 weeks on /1 week off. Weekly dose escalation of regorafenib from 80 mg to 160 mg/day will be employed as per the Redos strategy. Patients start the treatment 80 mg/day in week 1, with weekly dose escalation to 120 mg in week 2, then 160 mg week in 3 if no significant drug-related toxicities are observed. They will be continued on treatment with Regorafenib 160 md /day till tumor progression or toxicity. They will get MRI brain every 4 weeks during the study. RESULTS Primary endpoint is median Overall survival. Secondary endpoints include progression free survival at 6 months and the median time to progression and objective response rate using the modified RANO criteria. The overall safety and tolerability of regorafenib by CTCAE version 5.0. will also be reported. CONCLUSION This is an ongoing clinical trial.

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RTID-05. INDIGO: A GLOBAL, RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF VORASIDENIB (AG-881) VS PLACEBO IN PATIENTS WITH RESIDUAL/RECURRENT GRADE II GLIOMA WITH AN ISOCITRATE DEHYDROGENASE 1/2 (IDH1/2) MUTATION

Neuro-Oncology ◽

10.1093/neuonc/noaa215.810 ◽

2020 ◽

Vol 22 (Supplement_2) ◽

pp. ii194-ii194

Author(s):

Ingo Mellinghoff ◽

Martin van den Bent ◽

Jennifer Clarke ◽

Elizabeth Maher ◽

Katherine Peters ◽

...

Keyword(s):

High Risk ◽

Dose Escalation ◽

Objective Response ◽

Data Monitoring Committee ◽

Progression Free Survival ◽

High Risk Population ◽

Low Grade ◽

Who Grade ◽

Free Survival ◽

Grade Ii

Abstract BACKGROUND Low-grade gliomas (LGGs; WHO grade II) are incurable and ultimately progress to high-grade gliomas. The current treatment options are surgery followed by observation (“watch and wait”) for patients with lower risk for disease progression or postoperative chemoradiotherapy (high-risk population). There are no approved targeted therapies. IDH1 and IDH2 mutations (mIDH1/2) occur in approximately 80% and 4% of LGGs, respectively, and promote tumorigenesis via neomorphic production of D-2-hydroxyglutarate. Vorasidenib, an oral, potent, reversible, brain-penetrant pan-inhibitor of mIDH1/2, was evaluated in 76 patients with glioma in two phase 1 studies (dose escalation and perioperative) and was associated with a favorable safety profile at daily doses below 100 mg. Preliminary clinical activity was observed in non-enhancing glioma patients in both studies, with an objective response rate (ORR) of 18.2% and median progression-free survival of 31.4 months in the dose escalation study. METHODS Approximately 366 patients will be randomized 1:1 to vorasidenib (50 mg QD) or matched placebo and stratified by 1p19q status (intact vs co-deleted). Key eligibility criteria: age ≥ 12 years; grade II oligodendroglioma or astrocytoma (per WHO 2016 criteria) not in need of immediate treatment and without high-risk features; centrally confirmed mIDH1/2 status; ≥ 1 surgery for glioma with most recent ≥ 1 year but ≤ 5 years before randomization, and no other anticancer therapy; Karnofsky performance status ≥ 80%; and centrally confirmed measurable, non-enhancing disease evaluable by magnetic resonance imaging. Crossover from placebo to the vorasidenib arm is permitted upon centrally confirmed radiographic progression per RANO-LGG criteria. Primary endpoint: progression-free survival assessed by independent review. Secondary endpoints: safety and tolerability, tumor growth rate assessed by volume, ORR, overall survival, and quality of life. Clinical data will be reviewed regularly by an independent data monitoring committee. The study is currently enrolling patients in the US, with additional countries planned (NCT04164901).

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Effectiveness of nivolumab affected by prior cetuximab use and neck dissection in Japanese patients with recurrent or metastatic head and neck cancer: results from a retrospective observational study in a real-world setting

International Journal of Clinical Oncology ◽

10.1007/s10147-021-01900-4 ◽

2021 ◽

Author(s):

Shin Kariya ◽

Yasushi Shimizu ◽

Nobuhiro Hanai ◽

Ryuji Yasumatsu ◽

Tomoya Yokota ◽

...

Keyword(s):

Head And Neck Cancer ◽

Head And Neck ◽

Neck Dissection ◽

Neck Cancer ◽

Median Overall Survival ◽

Response Rate ◽

Objective Response ◽

Progression Free Survival ◽

Japanese Patients ◽

Free Survival

Abstract Background To examine the effect of prior use of cetuximab and neck dissection on the effectiveness of nivolumab, we conducted a large-scale subgroup analysis in Japanese patients with recurrent/metastatic head and neck cancer. Methods Data on the effectiveness of nivolumab were extracted from patient medical records. All patients were analyzed for effectiveness by prior cetuximab use. In the analyses for prior neck dissection, only patients with locally advanced disease were included. Results Of 256 patients analyzed, 155 had received prior cetuximab. Nineteen of 50 patients with local recurrence underwent neck dissection. The objective response rate was 14.7 vs 17.2% (p = 0.6116), median progression-free survival was 2.0 vs 3.1 months (p = 0.0261), and median overall survival was 8.4 vs 12 months (p = 0.0548) with vs without prior cetuximab use, respectively. The objective response rate was 23.1 vs 25.9% (p = 0.8455), median progression-free survival was 1.8 vs 3.0 months (p = 0.6650), and median overall survival was 9.1 vs 9.9 months (p = 0.5289) with vs without neck dissection, respectively. Conclusions These findings support the use of nivolumab for patients with recurrent/metastatic head and neck cancer regardless of prior cetuximab use or neck dissection history. Trial registration number UMIN-CTR (UMIN000032600), Clinicaltrials.gov (NCT03569436)

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