Efficacy of cetuximab after immunotherapy (IO) in advanced cutaneous squamous cell carcinoma (CSCC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9562-9562
Author(s):  
Julian Andres Marin-Acevedo ◽  
Bethany Withycombe ◽  
Youngchul Kim ◽  
Zeynep Eroglu ◽  
Joseph Markowitz ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Acquired Resistance ◽  
Standard Of Care ◽  
Line Treatment ◽  
Second Line ◽  
Survival Times ◽  
Entire Cohort ◽  
Overall Response ◽  
Curative Radiotherapy

9562 Background: Anti-PD1 (aPD1) monotherapy with cemiplimab-rwlc or pembrolizumab is now considered standard of care for first-line management of advanced CSCC not amenable to surgery or curative radiotherapy. Previously chemotherapy or anti-EGFR agents were commonly used for these patients albeit with modest efficacy and limited duration of response. In prospective evaluation, the overall response rate (ORR) to cetuximab was 28% with disease control rate (DCR) of 69% at 6 weeks. The efficacy of second-line treatment following primary or acquired resistance to aPD1 therapy is not known. We investigated the activity of cetuximab in patients who progressed on previous IO therapy. Methods: We performed a single institution retrospective review from 9/28/18 (US approval date of cemiplimab-rwlc for CSCC) through 11/30/20 of patients with locally advanced or metastatic CSCC who received cetuximab after prior IO therapy. We identified patients who received cetuximab either immediately following IO therapy (cohort A) or as a subsequent line not immediately following IO therapy (cohort B). Primary endpoint was ORR with secondary endpoints of DCR, survival and toxicity. Median follow-up and survival times were calculated using the Kaplan-Meier method. Results: Thirteen patients, median age 72 years (62-82), all Caucasian, and 11 males (85%) were included in this study. Eleven pts received cetuximab immediately post-IO progression; two had additional intervening therapy post-IO before receiving cetuximab. Three patients received concurrent radiotherapy (palliative or definitive) with cetuximab. The ORR to cetuximab was 54% (7/13) including 1 complete and 6 partial responses. The cumulative 6-month DCR was 77%. All responses were observed in cohort A; both patients in cohort B had progressive disease as best response. Six of 7 initial responses are ongoing, including 3 in whom cetuximab was discontinued. At a median follow-up of 9.1 months, the median PFS has not been reached for the entire cohort. There were no unanticipated toxicities to cetuximab with rash (77%) and hypomagnesemia (54%) being the most common adverse events. Conclusions: In advanced CSCC, cetuximab used immediately after progression on aPD1 therapy yields notably higher and durable overall response than previously reported in the pre-IO therapy era. If validated in a larger dataset, this should be the preferred therapy for second-line treatment in advanced CSCC. Further exploration into the mechanism of this high efficacy of anti-EGFR therapy post aPD1 therapy is warranted.

scholarly journals Paradigm Shifting of Systemic Chemotherapy for Unresectable Pancreatic Cancer in Japan

2019 ◽  
Vol 8 (8) ◽  
pp. 1170 ◽  
Author(s):  
Junji Furuse
Keyword(s):  
Pancreatic Cancer ◽  
Systemic Chemotherapy ◽  
Locally Advanced ◽  
Standard Of Care ◽  
Phase Iii ◽  
Unresectable Pancreatic Cancer ◽  
Line Treatment ◽  
Second Line ◽  
Brca Mutations ◽  
Line Chemotherapy

Systemic chemotherapy plays an important role in the treatment of pancreatic cancer, to improve the survival of patients with pancreatic cancer. Unresectable pancreatic cancer can be classified into three categories: metastatic, locally advanced, and hereditary pancreatic cancers. Furthermore, the second-line chemotherapy is required to prolong the survival. The combined regimens of oxaliplatin, irinotecan, fluorouracil and leucovorin (FOLFIRINOX) and gemcitabine plus nab-paclitaxel (GEM plus nab-PTX) have been recognized as the standard of care for advanced pancreatic cancer. However, the consensus of selection of the first-line chemotherapy still remains. Randomized controlled trials (RCTs) between FOLFIRINOX and GEM plus nab-PTX are ongoing for locally advanced and metastatic disease in Japan, respectively. Hereditary pancreatic cancer, especially associated with BRCA mutations, is responsive to platinum-containing regimens and/or poly (ADP-ribose) polymerase (PARP) inhibitors. It is becoming more important to examine the presence/absence of BRCA mutations to select the appropriate treatment strategy for individual patients. Although some S-1-based regimens have been investigated in the second-line treatment after GEM-based chemotherapy in Japan, no regime demonstrated survival benefit. Nanoliposomal irinotecan (nal-IRI) plus FF has been established as the standard of care in the second-line treatment in a global phase III trial (NAPOLI-1). A randomized phase II trial comparing FF plus nal-IRI with FF alone was also conducted in Japan to examine the efficacy and safety of the FF plus nal-IRI in Japanese patients.

A Rational Sequencing of Anti-Angiogenic Agents as Second-Line Treatment Choice for mCRC Patients Progressing After a Bevacizumab-Based First Line

2020 ◽  
pp. 14-19
Author(s):  
Sara De Dosso
Keyword(s):  
Acquired Resistance ◽  
Predictive Biomarker ◽  
Cancer Therapies ◽  
Vascular Endothelial ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Vegf Pathway ◽  
Effective Choice ◽  
Endothelial Growth Factor

A large proportion of patients with metastatic colorectal cancer (mCRC) experience disease progression after first-line treatment with chemotherapy and bevacizumab, an anti-angiogenic agent, as a result of acquired resistance. However, blocking angiogenesis by targeted therapy towards the vascular endothelial growth factor (VEGF) pathway still forms an essential part of the second-line treatment strategy. Although three approved evidence-based choices for angiogenic agents (continuing treatment with bevacizumab, ramucirumab and aflibercept) are currently available in the second line, making the most effective choice is challenging due to the lack of studies directly comparing these agents. Moreover, despite huge investigational efforts, no predictive biomarker for anti-angiogenic cancer therapies could be identified so far.

scholarly journals Sequential Treatment of Metastatic Adenocarcinoma of the Pancreatic Duct with Liver Metastasis Following the NAPOLI-1 Study Protocol with nal-Irinotecan plus 5-FU in the Second Line

2020 ◽  
Vol 13 (1) ◽  
pp. 79-84
Author(s):  
Dilara Akhoundova Sanoyan ◽  
Cäcilia S. Reiner ◽  
Panagiota Papageorgiou ◽  
Alexander R. Siebenhüner
Keyword(s):  
Systemic Treatment ◽  
Sequential Treatment ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Curative Surgery ◽  
To Receive

Pancreatic ductal adenocarcinoma (PDAC) is typically diagnosed at an advanced or metastatic stage, when curative surgery is not recommended. Therefore, the prognosis is poor for this dismal disease, with only 1–2% of the patients reaching the 5-year survival follow-up. Current advances in systemic treatment with gemcitabine regimens, specifically polychemotherapy with gemcitabine plus nab-paclitaxel or other multidrug regimens such as FOLFIRINOX in the first line, have improved disease control over time. This higher efficacy of systemic treatment enables metastatic PDAC patients to receive second-line treatment more often nowadays. Currently, there is only one regimen for second-line treatment approved by the EMA, FDA, and Swissmedic, based on the phase III NAPOLI-1 study. In this case report, we present an outstanding response to sequential treatment with gemcitabine plus nab-paclitaxel followed by second-line treatment with nal-irinotecan plus 5-fluorouracil.

Characteristics, treatment patterns, and economic burden of patients with metastatic cervical cancer receiving systemic anticancer therapy.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 51-51
Author(s):  
Xiaoyun Pan ◽  
Lincy S. Lal ◽  
John White ◽  
Seyed Hamidreza Mahmoudpour ◽  
Christian Valencia
Keyword(s):  
Cervical Cancer ◽  
Economic Burden ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Duration Of Treatment ◽  
Second Line Therapy ◽  
Treatment Regimens ◽  
Line Therapy

51 Background: In 2021, 14,480 patients are estimated to be diagnosed with cervical cancer in the US; 16% of patients are expected to have metastatic disease for whom the 5-year survival rate is 17.6% per SEER estimates. Patients with metastatic cervical cancer (mCC) are treated mainly with systemic therapy. This study aims to describe the clinical characteristics, demographics, treatment patterns, and economic burden of patients with mCC receiving systemic therapy. Methods: Eligible women had been diagnosed with cervical cancer, as evidenced by >2 outpatient or >1 inpatient claim in the Optum Research Database from January 2014 through January 2020. Patients were included if they had metastasis within 6 months before or after cervical cancer diagnosis, with evidence of systemic treatment on or after the latter of a claim date for cervical cancer disease or metastatic disease. The index date was the first-line treatment initiation date. Patients were required to have ≥6 months of pre-index continuous enrollment. The top 3 treatment regimens and median treatment duration by line of therapy were described. All-cause per-patient-per-month (PPPM) costs (2019 US dollars), including plan and patient paid amounts, were reported for full follow-up period from first-line and second-line therapy initiation. Results: The study sample consisted of 778 patients (mean age, 59 years; commercial, 58%; Medicare Advantage, 42%). The mean (median) follow-up period was 14 (9) months. Top baseline comorbidities were diseases of the urinary system (71%) and diseases of the female genital organs (70%), and the median Charlson comorbidity index was 7. In the first line, 80% of patients received platinum-based therapy and 23% received bevacizumab (bev). Of 778 patients, only 294 (38%) received second-line therapy, with 34% receiving bev. Top first-line treatment regimens were carboplatin + paclitaxel (27%), cisplatin (21%), and bev + carboplatin + paclitaxel (10%); the median (95% CI) duration of treatment was 3.4 (3.1-3.7) months. Top second-line treatment regimens were bev + carboplatin + paclitaxel (13%), carboplatin + paclitaxel (11%), and pembrolizumab (6%); the median duration of treatment was 3.8 (3.1-4.2) months. Mean all-cause total PPPM costs were $19,519 from first-line and $22,660 second-line therapy initiation (table). Conclusions: This study indicates that real-world mCC patients have short treatment durations and significant economic burden with first-line and second-line therapy. Novel therapies associated with greater clinical benefits in patients with mCC may provide economic benefit.[Table: see text]

scholarly journals Is Gluten the Only Culprit for Non-Celiac Gluten/Wheat Sensitivity?

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3785
Author(s):  
Maria Gloria Mumolo ◽  
Francesco Rettura ◽  
Sara Melissari ◽  
Francesco Costa ◽  
Angelo Ricchiuti ◽  
...  
Keyword(s):  
Wheat Germ ◽  
Line Treatment ◽  
Second Line ◽  
Gluten Free ◽  
Wheat Allergy ◽  
Media Messages ◽  
Wheat Sensitivity ◽  
Personalized Approach ◽  
Fodmap Diet

The gluten-free diet (GFD) has gained increasing popularity in recent years, supported by marketing campaigns, media messages and social networks. Nevertheless, real knowledge of gluten and GF-related implications for health is still poor among the general population. The GFD has also been suggested for non-celiac gluten/wheat sensitivity (NCG/WS), a clinical entity characterized by intestinal and extraintestinal symptoms induced by gluten ingestion in the absence of celiac disease (CD) or wheat allergy (WA). NCG/WS should be regarded as an “umbrella term” including a variety of different conditions where gluten is likely not the only factor responsible for triggering symptoms. Other compounds aside from gluten may be involved in the pathogenesis of NCG/WS. These include fructans, which are part of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs), amylase trypsin inhibitors (ATIs), wheat germ agglutinin (WGA) and glyphosate. The GFD might be an appropriate dietary approach for patients with self-reported gluten/wheat-dependent symptoms. A low-FODMAP diet (LFD) should be the first dietary option for patients referring symptoms more related to FODMAPs than gluten/wheat and the second-line treatment for those with self-reported gluten/wheat-related symptoms not responding to the GFD. A personalized approach, regular follow-up and the help of a skilled dietician are mandatory.

scholarly journals Second-Line Treatment of HER2-Positive Salivary Gland Tumor: Ado-Trastuzumab Emtansine (T-DM1) after Progression on Trastuzumab

2018 ◽  
Vol 11 (2) ◽  
pp. 252-257 ◽  
Author(s):  
Tatiana Strava Corrêa ◽  
Gustavo Duarte Ramos Matos ◽  
Marcos Segura ◽  
Carlos Henrique dos Anjos
Keyword(s):  
Disease Progression ◽  
Radical Neck Dissection ◽  
Locally Advanced ◽  
Pet Scan ◽  
Bone Lesions ◽  
Her2 Overexpression ◽  
Line Treatment ◽  
Second Line ◽  
Her2 Positive ◽  
Neck Lymph Node

Patients with salivary duct cancer (SDC) and HER2 overexpression could receive trastuzumab in combination with chemotherapy for metastatic disease. No standard treatment exists for patients with HER2-positive metastatic SDC after progression. We report an excellent patient response to second-line treatment with T-DM1 after progression on paclitaxel plus trastuzumab. Case Report: In June 2014, a 79-year-old male patient underwent right parotidectomy and ipsilateral radical neck dissection after the diagnosis of parotid carcinoma. Pathological staging demonstrated locally advanced disease with the involvement of 13 lymph nodes (levels I, II, III, and IV), with extracapsular extravasation. He underwent adjuvant radiotherapy ending in December 2014. A PET scan in March 2015 diagnosed recurrent and systemic disease, with bone lesions, neck lymph node involvement, and hepatic metastasis. The immunohistochemistry showed HER2 receptor overexpression (+3/+3). The patient received first-line trastuzumab plus paclitaxel beginning in April 2015. After 6 cycles, his response was confirmed by PET scan. In February 2016, he had symptoms of disease progression, and a PET scan revealed disease progression in the neck, bones, and liver. He started T-DM1 in April 2016. The neck skin lesions disappeared after 6 cycles, with low toxicity. PET scans performed every 3 months showed response in the liver and bone lesions. Conclusions: We report the case of a patient with SDC treated with T-DM1, with a very good response. Salivary carcinoma is a rare disease for which no randomized clinical trials are available. The maintenance of HER2 blockage might be important in this disease.

A National Registry of Patients Diagnosed with Multiple Myeloma in Taiwan.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4955-4955
Author(s):  
Tzeon-Jye Chiou ◽  
Shang-Yi Huang ◽  
Cheng-Shyong Chang ◽  
Sheng-Fung Lin ◽  
Sung-Nan Pei ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Response Rate ◽  
National Registry ◽  
Disease Stage ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Overall Response ◽  
Best Response ◽  
First Line Treatment

Abstract Abstract 4955 Background The diagnosis and treatment pattern in actual practice for patients with multiple myeloma has not been described in Taiwan. This is the first national registry survey with the introduction of conventional and novel anti-myeloma therapies in Taiwan. Methods The “Multiple Myeloma Observational Study” is a national-based observational registry survey conducted by the Hematology Society of Taiwan. All patients newly diagnosed with multiple myeloma within one year are eligible for inclusion. Information on treatment, treatment response and survival was obtained by medical record review. We report 115 patients with multiple myeloma in Taiwan who were enrolled from January 2006 to December 2008. Results The characteristics of 115 patients were examined according to age, gender and disease stage. The average age was 65 years. The number of male patient was 72 (62.6%); female patient, 43 (37.4%). The proportions of disease stage were: stage I, 14 (12.2%); stage II, 26 (22.6%); stage III, 75 (65.2%). All patients had received anti-myeloma agents as their first line treatment since diagnosis. The most commonly used regimen was combination of melphalan, prednisolone and thalidomide in 27 patients (23.5%) and combination of thalidomide and dexamethasone in 27 patients (23.5%); followed by combination of melphalan and prednisolone, 24 (20.9%); combination of vincristine, anthracycline and dexamethasone (VAD), 15 (13%), thalidomide alone, 9 (7.8%); dexamethasone alone, 5 (4.3%); combination of VAD and thalidomide, 2 (1.7%); others, 3 (2.6%). The adjunct therapies along with first line treatment include zoledronic acid, 59 (51.3%); clodronate, 16 (13.9%); pamidronat, 8 (7.0%); and epoietin, 5 (4.3%). The outcomes of treatment were also recorded. The overall response rate for first line treatment was 59.1%. The best response of combination of VAD and thalidomide was 100%, followed by combination of thalidomide and dexamethasone, 66.7%; combination of melphalan and prednisolone, 66.7%; the combination of melphalan, prednisolone and thalidomide, 63%, combination of vincristine, anthracycline and dexamethasone, 60%; thalidomide alone, 22.2%; dexamethasone alone, 20%. A total of 31 patients had received anti-myeloma agents as the second line treatment. The most commonly used treatment was thalidomide alone, received by 7 patients (22.6%); followed by combination of thalidomide and dexamethasone, 5 (16.1%); combination of melphalan, prednisolone and thalidomide, 5 (16.1%); VAD, 5 (16.1%); combination of melphalan and prednilolone, 3 (9.7%); dexamethasone alone, 3 (9.7%) and other regimen, 3 (9.7%). The overall response rate for second line treatment was 41.9%. The best response of the combination of melphalan, prednisolone and thalidomide, 66.7%, followed by combination of vincristine, anthracycline and dexamethasone, 60%; thalidomide alone 57.1%; the combination of thalidomide and dexamethasone, 40%. The median survival duration was still not achieved yet. Conclusions The results of this national registry show that the choice of treatments in multiple myeloma covers a wide range of therapeutic modality. The overall response of first line treatment and second line treatment was comparable to the result of other registry studies. Disclosures Chiou: Janssen-Cilag Taiwan: Honoraria, Research Funding. Lin:Janssen-Cilag Taiwan: Honoraria. Chang:Janssen-Cilag Taiwan: Honoraria. Hsiao:Janssen-Cilag Taiwan: Honoraria.

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