Case series on the safety of mRNA COVID19 vaccines in cancer patients undergoing treatment.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e14562-e14562
Author(s):  
Faysal Haroun ◽  
Malak Alharbi ◽  
Alison Hong
Keyword(s):  
Side Effects ◽  
Cancer Therapy ◽  
Checkpoint Inhibitors ◽  
Performance Status ◽  
Single Agent ◽  
Case Series ◽  
Vaccine Uptake ◽  
Cancer Center ◽  
High Risk Population ◽  
Patients With Cancer

e14562 Background: Millions of vaccines have been administered since Emergency Use Authorization has been granted for two mRNA COVID-19 vaccines (mCV). The Center for Disease Control (CDC) and Prevention recommends that immunocompromised individuals with no contraindications to vaccines may receive an mCV. The CDC suggests that patients receiving cancer therapies should be consulted about the unknown vaccine safety profile and effectiveness. The American Society of Clinical Oncology recognizes that vaccine may reduce the risk of infection for individuals with cancer. Vaccine trials have not actively enrolled immunocompromised or patients on active cancer therapy; therefore, the potential side effects and efficacy of the mRNA vaccines in these individuals are unexplored. Per state guidelines, many patients with cancer undergoing treatment qualify for vaccination however current vaccine uptake in that population is unknown. Data in this specific high-risk population is needed to increase confidence in the vaccine. We explored adverse events (AE) to the mCV in a small cohort of patients undergoing cancer therapy. Methods: Our case series evaluated patients' tolerance to the voluntary but recommended 2 doses of the mCV while on chemotherapy (CX), checkpoint inhibitors (CPI) or tyrosine kinase inhibitors (TKI) at the George Washington University (GWU) Cancer Center in Washington DC. Patient chart review and phone interviews were conducted. Patients had independently signed up for the mCV at the GWU Hospital or through the DC Health Department. Patients were asked if they had experienced any of the commonly reported side effects listed by the CDC or others new symptoms receiving the vaccine. Results: 12 patients had voluntarily received the mCV, all patients were above the age of 65 with a mean age of 72 (66-85). ECOG performance status was 2 or above in 4 patients. 6 patients were receiving single agent CPI, 1 patient was on combination CX and CPI. 2 patients were on oral TKI for EGFR mutated lung cancer. 3 other patients were on combination CX with rituximab, ramucirumab or radiation. In the 2 patients on daily TKI, treatment was not interrupted for the mCV. In the 10 other patients, all but one patient received the mCV at least one week after the last therapy. Both mCV were tolerated without any life-threatening AE or hospitalization. Pain and swelling at the vaccine site were the most common local AE and reported in 7 patients. 6 patients reported systemic AE most commonly myalgia and headaches. Conclusions: This exploratory analysis in 12 patients with cancer undergoing treatment did not uncover any additional SE signals. Larger studies are needed to evaluate AE and efficacy and to guide recommendations for COVID19 vaccination in this patient population.

scholarly journals 411 Novel intratumoral agent, INT230–6 induces cancer cell death, increases tumor infiltrates and results in durable benefit alone or in combination with pembrolizumab in refractory patients

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A436-A436
Author(s):  
Anthony El-Khoueiry ◽  
Jacob Thomas ◽  
Anthony Olszanski ◽  
Nilofer Azad ◽  
Lewis Bender ◽  
...  
Keyword(s):  
Cell Death ◽  
T Cell ◽  
Cancer Cells ◽  
Checkpoint Inhibitors ◽  
Phase 1 ◽  
Single Agent ◽  
Systemic Exposure ◽  
Systemic Circulation ◽  
Cancer Center ◽  
Advanced Malignancy

BackgroundINT230-6 is a novel formulation of cisplatin and vinblastine with an amphiphilic cell penetration enhancer that has been shown to enhance dispersion of the drug throughout tumors and allow diffusion into cells when given intratumorally. In preclinical models, INT230-6 has resulted in cell death, dendritic cell influx, antigen presentation and T-cell engagement with strong synergy when combined with checkpoint inhibitorsMethodsThis phase 1/2 study evaluated Q2week injections of INT230-6 x 5 dosed by tumor volume alone or with 200 mg pembrolizumab IV Q3 weeks. Eligble patients had any advanced malignancy refractory to standard therapy with an injectable tumor.ResultsSixty subjects (median 3 prior therapies (range 0–10)) were enrolled (53 monotherapy, 7 combo). Median age was 60 (42–85). 19 different cancer types were accrued with breast cancer and sarcoma being the most frequent. Over 200 deep tumor injections were administered at doses of up to 172 ml of INT230-6 (86 mg of CIS, 17 mg of Vin). PK analysis revealed <5% of the drugs were measured in systemic circulation, indicative of minimal systemic exposure. There was no dose limiting toxicity. The most frequent monotherapy drug related AE’s reported were: injection-site pain 58%, nausea 37%, fatigue 33%, and vomiting 27% with only 18% of subjects experiencing a grade 3 AE (no grade 4 or 5). Rates were comparable for the single agent INT230-6 and the combination with pembrolizumab. In the overall monotherapy cohort, patients completing all 5 doses of INT230-6 over 56 days (n=16), the median overall survival has not yet been reached. after a median followup of 408 days. In the 5 evaluable patients who received the pembrolizumab combination, the median TTP has not been reached with a median follow up of 6 mo. Paired biopsies (pre, 1 month) were available in 10 monotherapy patients and revealed a median of 63% reduction in viable cancer cells on H&E (30% had no viable cancer) that was also associated with qualitative decreases in Ki67, increases of CD4 and CD8 T-cells and reduction in FoxP3 Tregs. Despite receiving only 2 month of monotherapy, short half lives of the active agents, and no subsequent therapies, 8 injected tumors continued to regress past 1 year.ConclusionsINT230-6 is well tolerated when administered intratumorally alone or in combination with pembrolizumab. Pharmacodynamic assessments provides proof of concept that this drug can reduce viable cancer cells and increases CD4/CD8 T-cell infiltrates leading to durable clinical benefit off treatment.Trial RegistrationNCT 03058289Ethics ApprovalThe study was approved by USC, Princess Margaret Cancer Center, Fox Chase, UMass, Columbia, and Johns Hopkins Institution’s Ethics BoardConsentWritten informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal

scholarly journals Combined lenvatinib and pembrolizumab as salvage therapy in advanced adrenal cortical carcinoma

2020 ◽  
Vol 8 (2) ◽  
pp. e001009
Author(s):  
Sara Bedrose ◽  
Kevin Charles Miller ◽  
Lina Altameemi ◽  
Mohamed S Ali ◽  
Sameh Nassar ◽  
...  
Keyword(s):  
Systemic Therapy ◽  
Salvage Therapy ◽  
Checkpoint Inhibitors ◽  
Single Agent ◽  
Case Series ◽  
Progression Free Survival ◽  
Adrenal Cortical Carcinoma ◽  
Retrospective Case ◽  
First Case ◽  
Platinum Based Chemotherapy

BackgroundThere is no effective systemic therapy for metastatic adrenal cortical carcinoma (ACC) after failure of platinum-based chemotherapy. The efficacies of single-agent oral multikinase inhibitors (MKIs) or salvage immune checkpoint inhibitors (CPIs) have been very limited. It is unknown whether combining CPIs, such as pembrolizumab (PEM), with other therapies, such as MKIs, could yield higher response rates in ACC, yet this combination has shown promise in other cancers. Herein, we describe the first case series using PEM in combination with the MKI lenvatinib (LEN) in patients with progressive, metastatic ACC.MethodsA retrospective case series describing the use of LEN/PEM as salvage therapy in patients with progressive/metastatic ACC.ResultsEight patients were treated with the LEN/PEM combination therapy. Half were female, and the median age at time of diagnosis was 38 years (range 21–49). Three (37.5%) patients had hormonally active ACC. The median number of prior lines of systemic therapy was 4 (range 2–9). Six (75%) patients had had disease progression on prior CPIs and five (62.5%) patients had progressed on prior MKI therapy. The median progression-free survival was 5.5 months (95% CI 1.8–not reached) and median duration of therapy was 8.5 months (range 2–22). Two (25%) patients had a partial response, one (12.5%) patient had stable disease, and five (62.5%) patients had progressive disease. None of the eight patients stopped therapy because of adverse events.ConclusionsIn our small cohort of heavily pretreated patients with ACC, the combination of LEN/PEM was associated with objective responses in a subset of patients without significant toxicity. This combination should be formally investigated in phase II clinical trial with robust correlative studies to identify predictors for response.

HSR19-085: A Real World Observational Assessment of the Impact of Immunotherapy on the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

2019 ◽  
Vol 17 (3.5) ◽  
pp. HSR19-085
Author(s):  
Belqis El Ferjani ◽  
Sheenu Chandwani ◽  
Meita Hirschmann ◽  
Seydeh Dibaj ◽  
Emily Roarty ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Performance Status ◽  
Single Agent ◽  
Small Cell ◽  
Cancer Center ◽  
Small Cell Lung ◽  
First Line ◽  
Treatment Choices ◽  
The Impact

Background: NSCLC is the leading cause of cancer-related mortality worldwide. Recently reported clinical trials have firmly established the role of PD-1 and PD-L1 inhibitors in the treatment of patients (pts) with metastatic NSCLC (mNSCLC). We have established the prospective, observational, real-world Advanced Non-Small Cell Lung Holistic Registry (ANCHoR) to understand how the advent of immunotherapy impacts treatment choices and clinical outcomes. Objectives: The aim of this analysis is to measure the impact of immunotherapy on the treatment choice for the first-line treatment of mNSCLC and to determine the link between PD-L1 expression and the treatment choices made in routine clinical practice at the MD Anderson Cancer Center (MDA). Methods: From May 1, 2017, to June 30, 2018, English-speaking pts with mNSCLC at MDA who provided written informed consent were enrolled in ANCHoR and longitudinally followed. The PD-L1 testing rates were captured and the treatment decisions made were also captured and tabulated. The time of data cutoff for this study is June 30, 2018. Results: Of the 296 pts enrolled in the registry at the time of data cutoff, there were 49.7% males, 82.1% white, 45.9% ≥65 years old, 69.3% smokers, 83.1% with an initial stage IV diagnosis, 87.2% with nonsquamous histology, 36.1% with bone metastasis, 29.4% with brain metastasis, 43.2% with 0–1 performance status, and 21.6% with a known EGFR or ALK mutation. A total of 233 pts had been tested for PD-L1 (78.7%). Predominant reasons for not testing (63 pts) include not having available tissue (26 pts) or the test was not requested by the physician (31 pts). As of June 30, 2018, 38.5% of patients received immunotherapy as first-line therapy either as a single agent (18.9%, 56 pts) or in combination with chemotherapy (19.6%, 58 pts). Only 35.8% of the patients received platinum doublet chemotherapy alone. Two pts received chemotherapy combined with an anti-angiogenesis agent (0.68%). Targeted therapy was utilized either as a single agent (20.6%) or in combination with immunotherapy (2.4%). Conclusion: Immunotherapy is now utilized as a single agent or in combination in more than one-third of patients with mNSCLC. These numbers are expected to increase as data from recently reported studies get incorporated into common clinical practice. Compared to historic experience, there has been a dramatic decline in the use of chemotherapy with an anti-angiogenesis agent.

Palliative cancer therapy during end of life at a regional cancer center in Norway in 2005 and 2009.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9040-9040
Author(s):  
Mari Aas Gynnild ◽  
Malin Anshushaug ◽  
Stein Kaasa ◽  
Anne Kvikstad ◽  
Bjørn Henning Grønberg
Keyword(s):  
Cancer Therapy ◽  
Medical Records ◽  
Median Overall Survival ◽  
Hematological Malignancy ◽  
Performance Status ◽  
National Registry ◽  
Cancer Center ◽  
Cancer Type ◽  
Case Methods ◽  
Curative Intention

9040 Background: With increasing number of available therapies, there is a risk that patients (pts) are overtreated. Palliative cancer therapy is mostly recommended for pts with good Performance Status (PS). In one study, 42 % of pts received chemotherapy (CTx) during the last 30 days of life – suggesting that this may not always be the case. Methods: All pts who, according to the national registry, died from cancer in our region in 2005 and 2009 were analyzed. Data were collected from individual medical records. Endpoints: Time from the end of palliative cancer therapy until death. Whether there were differences depending on age; type of cancer; year of death or if they were seen at a palliative care unit (PCU). PS when the last cancer therapy was initiated. Results: 616 pts died in 2005; 599 in 2009. We excluded 495 pts: No cancer therapy (n=260); no information of cancer (n=101); last therapy with curative intention (n=83); hematological malignancy (n=51). Median age 71 (6 - 99); 49 % men; median overall survival from diagnosis: 16.9 mos. Last therapy was radiotherapy (RT): 31 %; CTx: 40 %; hormonal: 15 %; surgery: 11 %. 4 % died from treatment complications. Median time from start of last CTx or RT until death: 100 days; from end of last CTx or RT: 63 days. Younger pts received more CTx and RT in the last 30 days: Age < 60: 28 %; 60-70: 23 % and 70+: 12 % (p<.001). The table shows the use of CTx and RT the last 30 and 14 days for the most common cancers. Among those who got CTx in the last 30 days (n=74); 54 % had PS 2; 14 % PS 3-4. Among those who got RT in the last 30 days (n=61), 31 % had PS 2; 54 % PS 3-4. Of the 49 % referred to the PCU, fewer received CTx or RT in the last 30 days (PCU: 14 %, no PCU: 22 %; p=.002) and 14 days (PCU: 5 %, no PCU: 12 %; p<.001). Conclusions: Many pts received cancer therapy the last month of life. The percentage varies with age, cancer type and was lower in 2009 than in 2005. Pts seen at the PCU received less CTx and RT. Many pts had a poorer PS at the start of last cancer therapy than recommended. [Table: see text]

Immunotherapy releated cardiomyopathy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14601-e14601
Author(s):  
Ozlem Sonmez ◽  
Ozlem Nuray Sever ◽  
Basak Oyan ◽  
Osman Gokhan Demir
Keyword(s):  
Side Effects ◽  
Checkpoint Inhibitors ◽  
Rare Complication ◽  
Single Agent ◽  
Tnf Alpha ◽  
Oncology Practice ◽  
And Control ◽  
Chemotherapy Agents ◽  
As Effects ◽  
Cessation Of Treatment

e14601 Background: Side effects of immunotherapies also differ from classical cytoxic chemotherapy agents such as effects. Cardiomyopathy is a relatively rare complication. Studies have shown that the risk of developing myocarditis is higher when the ipilimumab / nivolumab combination is used than when the single agent nivolumab is used. ImmunoCheckpoint inhibitors are associated with an increase in immunologic response and immunosuppressives such as corticosteroids, TNF-alpha antagonists and mycophenolate acetate are used in treatment.In this study, we aimed to report cardiac toxicity in patients who treated with immune checkpoint inhibitors. Methods: Forty patients who were treated with immunocheckpoint inhibitors were screened retrospectively at two centers in Turkey between August 2015 and January 2017 . Results: Twenty-eight of the patients were male (70%), 12 were female (30%); The median age was 61 (32-81) years. 23 (57.5%) patients received nivolumab and 16 (40 %) patients received pembrolizumab and 1(2.5%) patient received pembrolizumab/ipilimumab combination. Seven of the cases had immuno-related side effects (17.5%).In two of our patients, after the second cure of the treatment, diffuse edema and shortness of breath due to heart failure was detected. Echocardiography revealed a low ejection fraction. Methylprednisolone was started by cessation of treatment. One week after the symptoms improved rapidly and control ejection fractions normalized. One of these patients was diagnosed with malignant melanoma and the other with RCC , they using pembrolizumab and nivolumab respectively. Conclusions: In conclusion, side effects that may occur may lead to fatal outcomes, while immunotherapy, which is increasingly used in oncology practice, may result in satisfactory success in treatment. Patients and their relatives should be adequately informed about side effects caused by these agents, complaints should be carefully evaluated and treatment should be started without spending time.

Risk of gastrointestinal and hepatic toxicities in patients with cancer treated with poly adenosine diphosphate ribose polymerase inhibitors: A meta-analysis of seven phase III trials.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 219-219
Author(s):  
Myo Zaw ◽  
Anita Sultan ◽  
Sriman Swarup ◽  
Myat M. Han ◽  
Yin Mon Myat ◽  
...  
Keyword(s):  
Side Effects ◽  
Synthetic Lethality ◽  
Meta Analysis ◽  
Single Agent ◽  
Adenosine Diphosphate ◽  
Parp Inhibitors ◽  
Phase Iii ◽  
Control Group ◽  
Patients With Cancer ◽  
Phase Iii Trials

219 Background: Inhibition of poly adenosine diphosphate ribose polymerase (PARP) enzymes terminates an alternative DNA repair pathway, resulting in synthetic lethality in homologous recombination deficient tumors. Many PARP inhibitors have shown to improve survival in many solid tumors with noteworthy safety concerns. We undertook a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk of gastrointestinal (GI) and hepatic toxicities. Methods: We conducted a comprehensive literature search using MEDLINE, EMBASE databases and meeting abstracts from inception through June 2018. Phase III RCTs that mention GI toxicities and elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) as adverse effects were incorporated in the analysis. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR) with 95% confidence interval (CI). Random effects model was applied. Results: 3188 patients from 7 phase III RCTs with breast, ovarian and gastric cancer were eligible. Studies compared olaparib or niraparib or rucaparib versus placebo, olaparib versus single agent chemotherapy, iniparib + gemcitabine / carboplatin (GC) versus GC, veliparib + C versus C and olaparib + paclitaxel versus paclitaxel. The RR of all-grade side effects were as follows: diarrhea, 1.24 (95% CI: 1.08 – 1.42, P = 0.002); nausea, 1.53 (95% CI: 1.16 – 2.02, P = 0.002); vomiting, 1.46 (95% CI: 1.02 – 2.08, P = 0.03); elevated AST, 1.25 (95% CI: 0.58 – 2.67, P = 0.55); and elevated ALT, 1.61 (95% CI: 0.81 – 3.20, P = 0.16). The RR of high-grade side effects were as follows: diarrhea, 1.08 (95% CI: 0.52 – 2.24, P = 0.82); nausea, 1.81 (95% CI: 0.79 – 4.12, P = 0.15); vomiting, 1.99 (95% CI: 1.06 – 3.73, P = 0.03); elevated AST, 1.86 (95% CI: 0.45 – 7.55, P = 0.38); and elevated ALT, 1.33 (95% CI: 0.42 – 4.18, P = 0.62). Conclusions: Our study showed that the risk of developing all grades of vomiting as well as any-grade nausea and diarrhea was high in PARP inhibitors arm, compared to control group. Timely recognition and prompt intervention with good supportive care are entailed.

Predictors of benefits to chemoimmunotherapy (CIT) in stage IV non-small-cell lung cancer (NSCLC): A meta-analysis.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20595-e20595
Author(s):  
Hazem Edmond El-Osta ◽  
Anita Lyn Sabichi
Keyword(s):  
Liver Metastasis ◽  
Checkpoint Inhibitors ◽  
Meta Analysis ◽  
Performance Status ◽  
Random Effect ◽  
Single Agent ◽  
Random Effect Model ◽  
Phase Iii ◽  
Smoking History ◽  
Metastatic Nsclc

e20595 Background: Immune checkpoint inhibitors (ICIs) have changed the landscape of NSCLC therapy. In previous study, gender, smoking history, and PD-L1 status were found to influence the efficacy of ICI monotherapy in NSCLC. This meta-analysis evaluated the clinical and molecular factors predictive of benefit from the addition of ICIs to first-line (1L) chemotherapy in metastatic NSCLC. Methods: Using the random effect model, we computed and compared the pooled hazard ratio (HR) of progression-free survival (PFS) and overall survival (OS) among the selected subgroups. The correlation between PD-L1 expression level and outcome was analyzed by meta-regression. Results: 7 phase III randomized trials comparing CIT vs. chemo in the 1L treatment of stage 4 NSCLC were included. CIT evenly improved the PFS irrespective of age, gender, histology, smoking history and ECOG performance status (PS). While patients (pts) with liver metastasis or ALK/EGFR aberration had greater PFS with the addition of ICI to Bevacizumab (BEV) based chemo regimen, the derived benefit was no longer statistically significant among pts treated with non-BEV-based regimens. Whereas the PFS superiority conferred by CIT was noticed across all PD-L1 expression subgroups, the benefit correlated with PD-L1 level and was more pronounced in the “PD-L1 high” subset. Except for pts with EGFR/ALK abnormalities, squamous histology or liver metastasis, CIT yielded a consistent amelioration of OS across the other selected subgroups. Conclusions: Survival advantage associated with 1L CIT in metastatic NSCLC was observed in different pts population including those for which single-agent ICI has limited therapeutic benefit. Our findings support the role of chemo +/- VEGF blockade as enhancer of ICIs activity even in “less immunogenic” context. [Table: see text]

Use of Palliative Chemo- and Radiotherapy at the End of Life in Patients With Cancer: A Retrospective Cohort Study

2016 ◽  
Vol 34 (9) ◽  
pp. 801-805 ◽  
Author(s):  
Zhe Zhang ◽  
Xiao-Li Gu ◽  
Meng-Lei Chen ◽  
Ming-Hui Liu ◽  
Wei-Wei Zhao ◽  
...  
Keyword(s):  
Cardiopulmonary Resuscitation ◽  
End Of Life ◽  
Medical Records ◽  
Palliative Chemotherapy ◽  
Performance Status ◽  
Terminally Ill ◽  
Cardiovascular Complications ◽  
Cancer Center ◽  
Patients With Cancer ◽  
Terminally Ill Patients

Background: Administration of chemotherapy and radiotherapy near the end of life is a frequently discussed issue nowadays. We have evaluated the factors associated with the use of chemotherapy and radiotherapy at the end of life among terminally ill patients in China. Methods: This study included the data from patients who had died from advanced cancer who underwent palliative chemotherapy and radiotherapy between January 2007 and December 2013 at the Department of Palliative Care of Fudan University, Shanghai Cancer Center. Data were collected from hospital medical records. Univariate and multivariate analyses were conducted to identify the factors independently associated with the use of chemo- and radiotherapy. Results: Among the 410 patients included (median age, 68 years; range, 18-93; 53% males), 47 (11.5%) underwent palliative chemotherapy and 28 (6.8%) underwent radiotherapy in the last 30 days. Age <65 years (odds ratio [OR]: 1.33, 95% confidence interval [CI]: 1.06-2.88), performance status <3 (OR: 3.95; 95% CI: 1.56-5.07), and cardiopulmonary resuscitation (OR: 4.09, 95% CI: 2.66-5.34) were independently associated with the use of chemotherapy. Performance status <3 (OR: 4.06, 95% CI: 2.17-5.83) and cardiopulmonary resuscitation (OR: 5.28, 95% CI: 3.77-7.21) were independently associated with the use of radiotherapy. Conclusion: The findings indicate that younger patients with a lower performance status who do not have complications are more likely to opt for chemo- or radiotherapy. Further, the use of palliative chemo- and radiotherapy should be considered carefully in terminally ill patients with cancer, as they seem to indicate a higher risk of cardiovascular complications requiring resuscitation.

Evaluation of barriers to clinical trial enrollment through a novel pharmacy quality assurance tool

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 17026-17026
Author(s):  
D. C. Vamos ◽  
M. P. Kane ◽  
J. Nishioka ◽  
S. Lisi ◽  
J. R. Neceskas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Performance Status ◽  
Pharmacy Service ◽  
Cancer Center ◽  
Limiting Factor ◽  
Available N ◽  
Patients With Cancer ◽  
Barriers To Enrollment ◽  
Pharmacy Quality

17026 Background: Clinical trials offer the best treatment for patients with cancer, yet less than 5 percent of adults and less than 60 percent of children are enrolled on clinical trials. To determine reasons for lack of enrollment on clinical trials and to assess areas for potential trial development, we designed a ‘non-protocol’ form for use at our center. Our goal was to assess deficiencies in our menu of trials, identify other barriers to enrollment, and to indirectly increase awareness of trials. Methods: Completion of a ‘non-protocol’ form was required by the pharmacy with the first set of new chemotherapy orders for all Cancer Institute of New Jersey ambulatory patients who were not enrolled on a clinical trial. The form required completion of one of three areas for lack of enrollment: trial availability, reason for ineligibility, or other reason for not enrolling the patient. Results: From June 2003 through December 2005, 474 forms were collected for patients not enrolled on a clinical trial. The median age of patients not enrolled on trial was 56 years (range 1 to 88 years) and females outnumbered males (69% vs 31%). Lack of trial availability limited enrollment for 51% of patients (n=241) while administration of standard therapy was listed for 10 patients. Of those patients where a trial was available (n=223), 65% (n=145) of patients were not eligible, most commonly due to performance status (n=55). The remaining 78 patients refused participation. To determine if implementation of this pharmacy service changed the reasons for lack of enrollment, the data was evaluated by year: Conclusion: Lack of trial availability has been a rate-limiting factor in enrollment on clinical trials at our center. The data generated from the implementation of this novel pharmacy service is of strategic importance to the center. It is reviewed with the tumor-focused groups of the cancer center to identify areas for developing clinical trials. [Table: see text] No significant financial relationships to disclose.

Sensitivity of treatment-free survival (TFS), a novel outcome, to subgroup analyses of patients (pts) with advanced melanoma (MEL) treated with immune checkpoint inhibitors (ICI).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9550-9550
Author(s):  
Charlene Mantia ◽  
Lillian Werner ◽  
Sumati Rao ◽  
Corey Ritchings ◽  
Ahmad A. Tarhini ◽  
...  
Keyword(s):  
Checkpoint Inhibitors ◽  
Performance Status ◽  
Single Agent ◽  
Graphical Analysis ◽  
Free Survival ◽  
Subgroup Differences ◽  
Therapy Initiation ◽  
Kaplan Meier ◽  
Restricted Mean Survival Time ◽  
And Gender

9550 Background: Many pts treated with ICIs can discontinue treatment and experience ongoing disease control and toxicity. We previously proposed a novel outcome, TFS, as the time between ICI therapy cessation and subsequent therapy initiation or death, with integrated graphical analysis to better characterize the unique effects of ICIs (ASCO 2018 #9531). In the CheckMate 067 and 069 trials of ipilimumab (IPI) and nivolumab (NIVO) alone or in combination (NIVO+IPI) in pts with MEL, the 36-month restricted mean TFS was 8.7, 4.6 and 11.1 mo, respectively. We explored the sensitivity of TFS to be informative of overall survival (OS) differences through subgroup analysis. Methods: Data from MEL pts in the CheckMate 067 and 069 trials were pooled and analyzed. TFS was defined as the area between the Kaplan-Meier curves for two endpoints, from randomization: (A) time to ICI therapy cessation; and (B) time to subsequent therapy initiation or death. TFS was estimated by restricted mean survival time until 36 mo since randomization. Differences in restricted mean TFS between subgroups of pts (such as PD-L1 status, lactate dehydrogenase [LDH], performance status [PS], gender) were calculated with bootstrapped 95% CIs. OS from randomization was also estimated. Results: Among 407 pts treated with NIVO+IPI, restricted mean TFS ranged from 8-13 mo across subgroups (Table). Subgroup differences in mean TFS were larger for prognostic factors LDH and PS and smaller in non-prognostic PD-L1 status and gender subgroups. Conclusions: Clinically meaningful TFS was seen across all subgroups. TFS was sensitive to prognostic subgroup differences. These results provide further support for TFS as a relevant clinical endpoint. Additional subgroups and comparisons with single agent NIVO and IPI arms will be presented at the meeting. [Table: see text]

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