scholarly journals Real-World Experience of Bevacizumab as First-Line Treatment for Ovarian Cancer: The GINECO ENCOURAGE Cohort of 468 French Patients

2021 ◽  
Vol 12 ◽  
Author(s):  
Dominique Berton ◽  
Anne Floquet ◽  
Willy Lescaut ◽  
Gabriel Baron ◽  
Marie-Christine Kaminsky ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Real World ◽  
Treated Patient ◽  
Blood Pressure Measurement ◽  
Real Life ◽  
Pegylated Liposomal Doxorubicin ◽  
Progression Free Survival ◽  
Treatment Schedule ◽  
Front Line ◽  
Free Survival

Introduction: Bevacizumab-containing therapy is considered a standard-of-care front-line option for stage IIIB–IV ovarian cancer based on results of randomized phase 3 trials. The multicenter non-interventional ENCOURAGE prospective cohort study assessed treatment administration and outcomes in the French real-world setting.Patients and Methods: Eligible patients were aged ≥ 18 years with planned bevacizumab-containing therapy for newly diagnosed ovarian cancer. The primary objective was to assess the safety profile of front-line bevacizumab in routine clinical practice; secondary objectives were to describe patient characteristics, indications/contraindications for bevacizumab, treatment regimens and co-medications, follow-up and monitoring, progression-free survival, and treatment at recurrence. In this non-interventional study, treatment was administered as chosen by the investigator and participation in the trial had no influence on the management of the disease.Results: Of 1,290 patients screened between April 2013 and February 2015, 468 were eligible. Most patients (86%) received bevacizumab 15 mg/kg every 3 weeks or equivalent, typically with carboplatin (99%) and paclitaxel (98%). The median duration of bevacizumab was 12.2 (range 0–28, interquartile range 6.9–14.9) months; 8% of patients discontinued bevacizumab because of toxicity. The most common adverse events were hypertension (38% of patients), fatigue (35%), and bleeding (32%). There were no treatment-related deaths. Most physicians (90%) reported blood pressure measurement immediately before each bevacizumab infusion and almost all (97%) reported monitoring for proteinuria before each bevacizumab infusion. Median progression-free survival was 17.4 (95% CI, 16.4–19.1) months. The 3-year overall survival rate was 62% (95% CI, 58–67%). The most commonly administered chemotherapies at recurrence were carboplatin and pegylated liposomal doxorubicin.Discussion: Clinical outcomes and tolerability with bevacizumab in this real-life setting are consistent with randomized trial results, notwithstanding differences in the treated patient population and treatment schedule.Clinical Trial Registration:ClinicalTrials.gov, Identifier NCT01832415.

scholarly journals Tolerance and Efficacy of L-Asparaginase during Induction of Extra-Nodal Natural Killer (NK/T) Lymphoma, Nasal Type, in Real-Life Experience

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5351-5351
Author(s):  
Salem Mansour ◽  
Louis Jacob ◽  
Sandy Amorim ◽  
Julien Potier ◽  
Pauline Brice ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Research Funding ◽  
Life Experience ◽  
Real Life ◽  
Progression Free Survival ◽  
Front Line ◽  
Advisory Committees ◽  
Free Survival ◽  
Nasal Type ◽  
T Lymphoma

Abstract Background. L-asparaginase (L-ASPA) based-chemotherapy (chemo) is one of the most efficient treatment for patients with extra-nodal NK/T nasal type lymphoma, in front- line or at relapse. This treatment is combined either with radiation therapy (RT) if localized or with high dose therapy plus autologous stem cell transplantation (HDT/ASCT) if disseminated. However it may be associated with toxicities that may impair efficacy and survival. Aim. The aim of this study was to report the real-life experience of L-asparaginase use in patients with NK/T nasal type lymphoma treated with L-ASPA based-chemotherapy and to identify risk factors associated with 1/ main adverse events and 2/ survivals. Patients and methods. Between July 2003 and June 2016, 28 patients were treated in our center for NK/T nasal type lymphoma. Four of them were excluded because they did not receive L-ASPA- based chemotherapy. Among the 24 pts included, 21 received the L-ASPA based-chemo as front-line therapy, and 3 pts as second line, either in association with gemzar and dexamethasone (n=14), or with methotrexate and dexamethasone (n=6), or with etoposide and dexamethasone (n=1). RT was delivered in 18 pts; HDT/ASCT in 3 pts; and both in 1 pt. Median number of injections of L-ASPA was 12 per patient (range 3-32). Grade 3-4 of toxicities (tox) were retrospectively assessed according to CTCAE V4.03, with a particular attention to 4 categories: hematological, hemostasis, liver and pancreatic dysfunctions. Progression-free (PFS) and overall survivals (OS) were analyzed from time of first L-ASPA injection, based on Kaplan Meier estimates. Results. Median age at diagnosis was 51 years (interquartile range, IQR : 40.7-61, ranging from 24-78). Sex ratio M/F was 0.71. PS was > 2 in 3 patients. Median body mass index (BMI) was 24 kg/m 2 (IQR: 23-25.7, ranging from 17-33). Stage was localized in nasal site in 20 patients, and disseminated (III-IV) in 4 patients, with bone marrow involvement in 2 pts, muscle in 1 pt, skin in 1 pt, and extensive nasal in 1 pt. LDH level was high in 10 (41.7%) patients. At diagnosis, EBV serum DNA was positive in 15/20 (75%) patients. All patients were negative for HBV, HIV, HCV. Abnormal baseline levels of ASAT/ ALAT (> 2N) were present in 2 patients, amylase/lipase (>1.5N) in 2 pts, bilirubine (2N) in 4 pts. Baseline anemia (< 10g/L) and thrombopenia (< 100 G/L) were present in 6 and 2 patients, respectively. Hemostastic parameters were normal in all patients. During the treatment, 10 (42%) patients developed gr3-4 hepatic toxicities, and 3 (13%) pts pancreatic toxicities, 6 (25%) pts hematologic toxicities, 3 (13%) pts hemostatic toxicities. These toxicities induced a reduction of treatment in 6 (25%) patients. Hematological toxicities were associated to baseline hemoglobin and platelets levels and to poor PS (p= 0.008; p= 0.014 ; p= 0.095, respectively). Hemostatic toxicities were associated to the stage of the disease, but not significantly (p= 0.076). No factor was associated for hepatic or pancreatic toxicities. Age and BMI were not significantly associated to any toxicity. A complete remission was achieved at the end of treatment in 12 patients (50%). At 2 years, progression- free survival and overall survival were 39% (95%CI, 20.3-76%) and 51.5% (95%CI, 30-89%), respectively. Presence of toxicities impacted the progression free survival and overall survival, though not significantly (p= 0.0635 ; p= 0.0737) (Figure 1) Conclusion. In this small retrospective analysis, we observed an impact of toxicities related to L-ASPA on the PFS and the OS of patients with extra-nodal NK/T lymphoma. The identification of the risk factors associated to these toxicities needs to analyze large cohorts of prospective trials. Figure 1 Figure 1. Disclosures Brice: Takeda Pharmaceuticals International Co.: Honoraria, Research Funding; Seattle Genetics: Research Funding; Roche: Honoraria; Gilead: Honoraria; Bristol Myers-Squibb: Honoraria. Thieblemont:Roche: Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bayer: Honoraria, Membership on an entity's Board of Directors or advisory committees.

A phase II study of pegylated liposomal doxorubicin oxaliplatin and cyclophosphamide as second-line treatment in relapsed ovarian carcinoma

2006 ◽  
Vol 16 (Suppl 1) ◽  
pp. 79-85 ◽  
Author(s):  
M. R. Valerio ◽  
P. Tagliaferri ◽  
F. Raspagliesi ◽  
F. Fulfaro ◽  
G. Badalamenti ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Median Survival ◽  
Liposomal Doxorubicin ◽  
Overall Response Rate ◽  
Response Rate ◽  
Pegylated Liposomal Doxorubicin ◽  
Progression Free Survival ◽  
Second Line ◽  
Free Survival ◽  
Grade 3

We carried out a phase II nonrandomized study to examine the level of activity of oxaliplatin, pegylated liposomal doxorubicin, and cyclophosphamide in a patient population with relapsed ovarian cancer pretreated with platinum derivatives and paclitaxel. Patients received oxaliplatin (85 mg/m2), pegylated liposomal doxorubicin (30 mg/m2), and cyclophosphamide (750 mg/m2). A total of 49 patients (39 assessable for toxicity and response) were enrolled in this trial. Neutropenia grade 3 was observed in six patients (15%) and anemia grade 3 in one patient (0.2%). Fatigue grade 1–2 occurred in 26 patients (66%), nausea/vomiting grade 1 in 23 patients (58%), and alopecia grade 1–2 in 19 patients (48%). Twenty-one (53%) patients experienced grade 1–2 peripheral neuropathy. The overall response rate was 46% (95% CI 23.6–68.7). Median progression-free survival was 28 weeks (range 12–52 weeks) and median survival was 45 weeks (range 26–136+ weeks). The mean duration of response was 34 weeks (range 16–52 weeks). In platinum-resistant and -refractory ovarian cancer patients, the overall response rate was 37% (CI 95% 14.4–60.8) with a progression-free survival of 28 weeks (range 12–52 weeks) and a median survival of 42 weeks (range 28–84 weeks). This combination chemotherapy is generally well tolerated and is an active second-line regimen against ovarian cancer.

Pegylated Liposomal Doxorubicin and Gemcitabine in a Fixed Dose Rate Infusion for the Treatment of Patients With Poor Prognosis of Recurrent Ovarian Cancer: A Phase Ib Study

2011 ◽  
Vol 21 (3) ◽  
pp. 478-485 ◽  
Author(s):  
Guillermo Crespo ◽  
Marta Sierra ◽  
Raquel Losa ◽  
José Pablo Berros ◽  
Noemí Villanueva ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Pegylated Liposomal Doxorubicin ◽  
Progression Free Survival ◽  
Recurrent Ovarian Cancer ◽  
Fixed Dose ◽  
Free Survival ◽  
Fixed Dose Rate ◽  
Fixed Dose Rate Infusion ◽  
Dose Limiting Toxicity ◽  
Rate Infusion

IntroductionPegylated liposomal doxorubicin (PLD) is currently the reference treatment for platinum-resistant ovarian cancer. The combination of PLD and gemcitabine and the administration of gemcitabine at a fixed dose rate infusion (FDRI) seem to have additive activity in this disease setting. We have launched a phase Ib study with the combination of FDRI gemcitabine followed by PLD in recurrent ovarian cancer with a platinum-free interval of less than 1 year, with parallel pharmacokinetic and pharmacogenetic studies.MethodsThe starting dose of gemcitabine was 1500 mg/m2, 10 mg/m2per minute, every 2 weeks (±250 mg gemcitabine titration depending on toxicity), followed by PLD 35 mg/m2every 4 weeks. Gemcitabine pharmacokinetics and equilibrative nucleoside transporter 1, deoxycytidine kinase, and ribonucleotide reductase M1 gene expression levels were studied.ResultsThirty-five patients were treated at 3 different dose levels (DL). Dose level 1 was not tolerated. Nonfrail patients continued to be treated at DL-1 (G 1250 mg/m2on day 1 and PLD 35 mg/m2on days 1 and 15). Of 10 evaluable nonfrail patients, 4 displayed dose-limiting toxicity. Frail patients were treated at DL-2 (G 1250 mg/m2on day 1 and PLD 35 mg/m2on days 1 and 15). Of the 12 evaluable frail patients, 3 developed dose-limiting toxicity. Neutropenia, palmar-plantar erythrodysesthesia and stomatitis were the most common toxicities. The response rate was 42.8% (95% confidence interval [CI], 34.5%-51.1%), with 17.1% (6/35) complete responses and 25.7% (9/35) partial responses. The median progression-free survival was 7.7 months (95% CI, 2.2-13.1). The median overall survival was 13.9 months (95% CI, 9.4-18.4). The administration of PLD after gemcitabine did not influence gemcitabine pharmacokinetics or its metabolites. The addition of PLD to gemcitabine caused a larger and longer induction of the ribonucleotide reductase M1 gene. Patients with higher baseline levels of deoxycytidine kinase had longer progression-free survival.ConclusionThe recommended dose for a phase II study of patients with recurrent ovarian cancer having poor prognosis is PLD, 35 mg/m2on day 1, and gemcitabine, 1000 mg/m2on days 1 and 15 delivered at an FDRI of 10 mg/m2per minute in 28-day cycles.

scholarly journals Pomalidomide and Dexamethasone Are Effective in Relapsed or Refractory Multiple Myeloma in a Real-Life Setting: A Multicenter Retrospective Study in Taiwan

2021 ◽  
Vol 11 ◽  
Author(s):  
Yu-Chin Hung ◽  
Jyh-Pyng Gau ◽  
Shang-Yi Huang ◽  
Bor-Sheng Ko ◽  
Chieh-Lin Jerry Teng
Keyword(s):  
Multiple Myeloma ◽  
Real World ◽  
Real Life ◽  
Progression Free Survival ◽  
High Dose ◽  
Free Survival ◽  
Refractory Multiple Myeloma ◽  
High Dose Dexamethasone ◽  
Real Life Setting ◽  
Multicenter Registry

BackgroundThe therapeutic options of relapsed or refractory multiple myeloma (RRMM) remain a challenge. The MM-003 trial demonstrated that RRMM patients treated with pomalidomide and dexamethasone (Pom/Dex) have better progression-free survival (PFS) than those treated with high-dose dexamethasone alone. However, the real-world effectiveness of Pom/Dex in these patients in Taiwan remains unclear.MethodsThis multicenter, registry-based study retrospectively reviewed the medical records of 49 consecutive patients undergoing Pom/Dex treatment for RRMM. We investigated the overall response rate (ORR) and PFS in these patients. The patients were stratified into two groups: those who received two (n=33) and those who received more than two (n=16) prior lines of treatment according to the numbers of regimens before Pom/Dex therapy. The differences in ORR and PFS between these two groups were further analyzed. We also analyzed factors attributed to disease progression.ResultsThe ORR was 47.7%, and the median PFS was 4.0 months (range, 0.1−21.1). Patients who received two prior lines of treatment had a higher ORR than those who received more than two prior lines of treatment (55.2% vs. 33.3%; p=0.045). The median PFS of these groups was 4.8 and 3.9 months, respectively (p=0.805). Primary lenalidomide refractoriness reduced the risk of myeloma progression following Pom/Dex treatment (hazard ratio, 0.14; p=0.001).ConclusionsThe median PFS following Pom/Dex treatment in Taiwanese RRMM patients in a real-world setting was similar to that reported by the MM-003 trial. Primary lenalidomide refractoriness should not be an obstacle for Pom/Dex treatment in RRMM.

Real-World Outcomes of Combination Chemotherapy with Trabectedin plus Pegylated Liposomal Doxorubicin in Patients with Recurrent Ovarian Cancer: A Single-Center Experience

Chemotherapy ◽  
2016 ◽  
Vol 61 (3) ◽  
pp. 122-126 ◽  
Author(s):  
Guillaume Moriceau ◽  
Romain Rivoirard ◽  
Benoîte Méry ◽  
Alexis Vallard ◽  
Cécile Pacaut ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Liposomal Doxorubicin ◽  
Performance Status ◽  
Real Life ◽  
Pegylated Liposomal Doxorubicin ◽  
Progression Free Survival ◽  
Recurrent Ovarian Cancer ◽  
Single Center ◽  
Disease Response ◽  
Single Center Experience

Background: Trabectedin plus pegylated liposomal doxorubicin (PLD) proved efficacious as second-line treatment for patients with recurrent ovarian cancer (ROC). Methods: We report a single-center retrospective analysis of the efficacy and tolerance of trabectedin 1.1 mg/m2 every 3 weeks in a cohort of real-life ROC patients. Results: From February 2012 to January 2014, 17 patients were treated with trabectedin alone or combined with PLD. Median age was 61 years (range: 48-78). Performance status was 0-1 in 16 patients (94%). Disease response rate was 53% and disease control rate was 76%. At the end of the follow-up, 8 patients (47%) were alive. Median overall survival was 17.6 months (95% CI 13.6 to not reached). Median progression-free survival was 6.7 months (95% CI 5.4-10.0). The most frequent grade 3-4 toxicities were neutropenia (n = 4, 24%) and nausea/vomiting (n = 4, 24%). Conclusion: Trabectedin combined with PLD seems efficient in and well tolerated by real-life ROC patients.

Real-world progression-free survival among patients with newly diagnosed advanced ovarian cancer: Does maintenance therapy work?

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18707-e18707
Author(s):  
Jinan Liu ◽  
John Chan ◽  
Janvi Sah ◽  
Eric M. Maiese ◽  
Oscar Bee ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Maintenance Therapy ◽  
Real World ◽  
Maintenance Treatment ◽  
Index Date ◽  
Progression Free Survival ◽  
Tumor Biomarker ◽  
Newly Diagnosed ◽  
Debulking Surgery ◽  
Free Survival

e18707 Background: Options for first-line (1L) maintenance therapy in ovarian cancer (OC) have evolved in the US in recent years, particularly with FDA approvals of poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors (PARPi). Olaparib was approved in 2018 for 1L maintenance treatment of patients (pts) with advanced OC with BRCA mutation and in 2020 as combination therapy with bevacizumab for 1L maintenance treatment of pts with homologous recombination deficient (HRd)–positive tumors. Additionally, the FDA approved niraparib in 2020 for maintenance treatment of pts with advanced OC regardless of tumor biomarker status. This study aimed to describe use and outcomes of 1L maintenance vs. active surveillance (AS) among PARPi-eligible pts with OC in a real-world setting prior to the most recent 2020 FDA approvals. Methods: This retrospective cohort study included pts with newly diagnosed stage III/IV OC who received 6–9 cycles of 1L platinum-based chemotherapy (PBC) and either primary debulking surgery or interval debulking surgery following neoadjuvant chemotherapy between January 1, 2016, and February 29, 2020, regardless of biomarker status, from the Flatiron Health database, a longitudinal electronic health record-derived database consisting of de-identified patient-level data that are curated via technology-enabled abstraction. The end of the last cycle of 1L PBC was defined as the index date. Pts who started second-line (2L) treatment within 2 months of the index date were excluded. Primary endpoint was time to initiation of 2L systemic therapy (as a surrogate for progression) or death. Inverse probability of treatment weighting and Cox proportional hazard model were used to adjust for baseline differences among pts on maintenance therapy and pts on AS. Results: A total of 463 pts were included in the study, 87.7% from community practices and 12.3% from academic institutions. Of the pts included, 21.0% received maintenance therapy, while 79.0% did not. Of those who received maintenance therapy, 48.5% received bevacizumab, 40.2% received PARPi (olaparib, rucaparib), and 11.3% received paclitaxel. Median progression-free survival (PFS) for pts who received 1L maintenance therapy was 16.1 months, compared with 12.2 months in pts who did not receive 1L maintenance therapy. After adjusting for baseline differences in characteristics and demographics, including age, race, stage of cancer, and BRCA status, pts on maintenance therapy had a statistically significant, 29% lower risk of progression or death than those receiving AS (hazard ratio: 0.71; 95% CI, 0.52–0.99; P= 0.04). Conclusions: In this real-world analysis, the majority of pts did not receive maintenance therapy; however, a PFS benefit was found in those receiving maintenance therapy. Further studies are needed to understand how biomarker status drives practice patterns.

Real-world evidence of poly ADP-ribose polymerase inhibitors in the treatment of ovarian cancer: A systematic literature review

2020 ◽  
Vol 26 (8) ◽  
pp. 1977-1986
Author(s):  
Eric P Borrelli ◽  
Conor G McGladrigan
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Real World ◽  
Median Overall Survival ◽  
Advanced Disease ◽  
Progression Free Survival ◽  
Free Survival ◽  
The Real ◽  
Median Progression Free Survival ◽  
Polymerase Inhibitors

Objective The treatment landscape for ovarian cancer has shifted in recent years with the approval of poly ADP-ribose polymerase inhibitors in 2014. Most patients with ovarian cancer have advanced disease at diagnosis. Understanding how treatments for advanced disease work in real-world settings must be assessed to provide care for these patients. Therefore, the objective of this study was to locate and assess real-world studies measuring the safety and effectiveness of poly ADP-ribose polymerase inhibitors and analyze the results. Data sources: A targeted systematic literature review was conducted in April 2020 of PubMed/Medline. Inclusion criteria consisted of observational studies using real-world data of olaparib, rucaparib, or niraparib as an intervention in the treatment of ovarian cancer. In addition, studies needed to assess either clinical effectiveness or safety. Once studies were identified, we aimed to narratively describe the studies’ patient population, intervention effectiveness, and/or safety. Data summary: Our systematic review identified six studies assessing the real-world effectiveness and/or safety of poly ADP-ribose polymerase inhibitors, with five assessing olaparib, one assessing poly ADP-ribose polymerase inhibitors as a composite, and none assessing either niraparib or rucaparib. The median progression free survival in the real-world trials for olaparib ranged from 12.7 to 15.6 months. The median overall survival in the real-world trials for olaparib ranged from 30.9 to 35.4 months. Rates of treatment discontinuation due to adverse events for olaparib ranged from 4.4% to 12.5%. Conclusions The identified studies showed slightly higher, but comparable results for median progression free survival, median overall survival, and discontinuation due to adverse events compared to the respective randomized controlled trials.

scholarly journals Role of front-line bevacizumab in advanced ovarian cancer: the OSCAR study

2019 ◽  
Vol 30 (2) ◽  
pp. 213-220 ◽  
Author(s):  
Marcia Hall ◽  
Gianfilippo Bertelli ◽  
Louise Li ◽  
Clare Green ◽  
Steve Chan ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
High Risk ◽  
Advanced Ovarian Cancer ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Oncologic Outcomes ◽  
Front Line ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
The Impact

ObjectiveTwo randomized phase III trials demonstrated the efficacy and safety of combining bevacizumab with front-line carboplatin/paclitaxel for advanced ovarian cancer. The OSCAR (NCT01863693) study assessed the impact of front-line bevacizumab-containing therapy on safety and oncologic outcomes in patients with advanced ovarian cancer in the UK.MethodsBetween May 2013 and April 2015, patients with high-risk stage IIIB–IV advanced ovarian cancer received bevacizumab (7.5 or 15 mg/kg every 3 weeks, typically for ≤12 months, per UK clinical practice) combined with front-line chemotherapy, with bevacizumab continued as maintenance therapy. Co-primary endpoints were progression-free survival and safety (NCI-CTCAE v4.0). Patients were evaluated per standard practice/physician’s discretion.ResultsA total of 299 patients received bevacizumab-containing therapy. The median age was 64 years (range 31–83); 80 patients (27%) were aged ≥70 years. Surgical interventions were primary debulking in 21%, interval debulking in 36%, and none in 43%. Most patients (93%) received bevacizumab 7.5 mg/kg with carboplatin/paclitaxel. Median duration of bevacizumab was 10.5 months(range <0.1–41.4); bevacizumab and chemotherapy were given in combination for a median of three cycles (range 1–10). Median progression-free survival was 15.4 (95% CI 14.5 to 16.9) months. Subgroup analyses according to prior surgery showed median progression-free survival of 20.8, 16.1, and 13.6 months in patients with primary debulking, interval debulking, and no surgery, respectively. Median progression-free survival was 16.1 vs 14.8 months in patients aged <70 versus ≥70 years, respectively. The 1-year overall survival rate was 94%. Grade 3/4 adverse events occurred in 54% of patients, the most common being hypertension (16%) and neutropenia (5%). Thirty-five patients (12%) discontinued bevacizumab for toxicity (most often for proteinuria (2%)).ConclusionsMedian progression-free survival in this study was similar to that in the high-risk subgroup of the ICON7 phase III trial. Median progression-free survival was shortest in patients who did not undergo surgery.

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