Incorporation of HIPEC into a high volume ovarian cancer program: Initial results and outcomes.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e17040-e17040
Author(s):  
Aliza L. Leiser ◽  
Eugenia Girda ◽  
Ruth D. Stephenson ◽  
Mihae Song ◽  
Alexandre Buckley de Meritens ◽  
...  

e17040 Background: HIPEC showed a progression free survival when incorporated into interval cytoreductive surgery for ovarian cancer patients in a recent phase lll trial. This has led to a paradigm shift at many institutions and the consideration of HIPEC. The goal of this study is to report on the initiation of this program and change in practice at a high volume cancer center over a period of 1 year. Methods: Reviewed surgical cases from 1/2018 through 1/2019 where patients were thought to have a primary ovarian or fallopian tube cancer. Variables included age, stage, histology, primary or interval debulking surgery, number of neoadjuvant (NAJ) chemotherapy cycles. HIPEC patients were selected out and variables examined included intraoperative procedures, optimal cytoreduction, type of chemotherapy administered, postoperative complications, and ability to receive consolidation chemotherapy. Results: 35 cases where ovarian cancer known or suspected preoperatively. 23 patients had primary surgery consisting of tah/bso/surgical staging/tumor debulking. 0/23 of these patients were offered HIPEC chemotherapy as an upfront strategy. 12 patients received neoadjuvant chemotherapy for recurrent (2) or advanced (10) disease. 11/12 of these patients proceeded to an interval surgery. 6/11 (54%) were planned for HIPEC. This was aborted in 1/6 because of thrombocytopenia. 5/6 patients went on to receive HIPEC. They received 3-6 cycles of NAJ chemotherapy, platinum and taxane. 3/5 also received preoperative Avastin. All had R0 resection. 1 patient had a bowel resection. Either carboplatin or cisplatin was used for HIPEC over 90 minutes. 2/5 patients had postoperative G2-3 cytopenias. 3/5 patients were able to receive consolidation chemotherapy, 2 of them within six weeks of surgery and with Avastin containing regimens. Conclusions: In a large volume center initiating a HIPEC ovarian cancer program in less than one years’ time, HIPEC was offered to 50% of patients undergoing interval debulking for Stage III or IV serous ovarian cancer after NAJ chemotherapy and in rare cases for patients with recurrent cancer planned for cytoreduction. Patients may go on to receive postoperative chemotherapy but may have prolonged cytopenias and consolidation therapy delays. HIPEC was not incorporated into an upfront surgical strategy.[Table: see text]

2012 ◽  
Vol 30 (18_suppl) ◽  
pp. LBA5000-LBA5000 ◽  
Author(s):  
Ignace B. Vergote ◽  
Florence Joly ◽  
Dionyssios Katsaros ◽  
Corneel Coens ◽  
Alexander Reinthaller ◽  
...  

LBA5000 Background: The epidermal growth factor receptor (EGFR) has been found to be overexpressed in 55-98% of advanced epithelial ovarian cancer. This trial evaluated the efficacy of maintenance erlotinib, an EGFR tyrosine kinase inhibitor, after first-line chemotherapy. Methods: Eligible patients (pts) had high-risk FIGO stage I or stage II-IV epithelial ovarian, peritoneal or fallopian tube cancer and were not selected for EGFR expression. All patients underwent first line therapy (6-9 cycles of 3-weekly platinum-based chemotherapy (CT)) and showed no signs of progression at the end of CT. Patients were randomised to maintenance erlotinib 150 mg daily for 2 years or observation. Primary endpoint was progression-free survival (PFS) by RECIST in combination with GCIG CA125 criteria. The final design provided 80% power to detect a PFS hazard ratio (HR) of 0.80 with 2-sided log-rank test at 5% after 632 events in 830 patients. Stratifications factors were stage, institution, age, response to and type of first-line CT. Immunohistochemistry (IHC) and FISH for EGFR, and EGFR mutation analyses were performed in 330 patients. The study was registered as NCT00263822 and EudraCT number 2004-004333-34. Results: Between Oct 2005 and Feb 2008, 835 pts were randomised by 125 institutions from 10 countries. The most important baseline characteristics, PFS and OS are summarized in the table. Median follow-up was 51 months. 25% of the patients stopped erlotinib due to side effects (of these 67% due to rash). The predictive value of IHC and FISH for EGFR, and EGFR mutations are being evaluated and will be presented at the meeting. Conclusions: In the overall study populationmaintenance erlotinib after first-line treatment in ovarian cancer did not improve progression-free or overall survival. [Table: see text]


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3570-3570
Author(s):  
Shanu Jain ◽  
Reena Engineer ◽  
Vikas S. Ostwal ◽  
Anant Ramaswamy ◽  
Supriya Chopra ◽  
...  

3570 Background: To evaluate the feasibility and efficacy of SCRT followed by chemotherapy (CT) in locally advanced metastatic rectal cancer (LAmRC). Methods: Between May 2012 and August 2015, 70 patients having LAmRC with or without circumferential resection margin (CRM) positive disease treated with SCRT (25Gy/5#) followed by 3-6 cycles of capecitabine/5-FU, oxaliplatin or irinotecan based CT were assessed. Results: Fifty one had single site metastases (23 liver, 16 lung, 10 retroperitoneal lymph nodes and 2 peritoneum), 9 had combined lung and liver metastases and 10 had combined nodal and organ metastases. Sixty five (93%) patients could complete planned SCRT and 3-6 cycles of chemotherapy (starting 7-10 days after RT completion) with dose reduction in 21 (32%) patients owing to CT induced toxicities. Local tumor down-staging was achieved in 43 (61.4%) patients and the rest had a stable primary disease. Radiologically, CRM was free in 25 (46.3%) patients out of 54 initially involved. Surgery of the primary was planned in 38 (58%). R0 resection in 26 (40%), R1 in 7 (pCRM positive). Five refused surgery in spite of being resectable. Rest of the 27 (41%) received palliative CT due to progression of distant disease. Metastatectomy along with primary surgery was done in 16 (25%) patients. Median follow up was 29 months. Overall survival (OS) of entire cohort at 2 years was 40%. Median progression free survival (PFS) and OS of patients with resected primary was 17 (10-24) and 37 (28-45) months, respectively, which is significantly better than those who were not resected (p = < 0.001). Of these 33 resected patients, 13 (39.4%) are disease free and 20 have progressed (16 distant, 2 loco-regional and 2 local and systemic). Conclusions: Upfront SCRT followed by systemic CT in an unresectable group of metastatic rectal cancer patients is safe and feasible and is having encouraging results in terms of downstaging and resectability of the primary. [Table: see text]


2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 755-755
Author(s):  
Seung-Hoon Beom ◽  
Joong Bae Ahn ◽  
Sang Joon Shin ◽  
Minkyu Jung

755 Background: Oxaliplatin-based chemotherapy is commonly used chemotherapy in the adjuvant setting for colorectal cancer patients. In clinical practice, those patients may be retreated with oxaliplatin after relapse. The efficacy and predictive factor of oxaliplatin re-treatment are little known. Methods: We carried out a retrospective study of 53 consecutive patients who underwent surgery and adjuvant FOLFOX chemotherapy and who were re-treated oxaliplatin-based chemotherapy after relapse at Yonsei Cancer Center from April 2009 through October 2015. The main end-point was progression-free survival (PFS). Results: Among enrolled patients, 33 (62.2%) received curative resection in initially non-metastatic setting and the other 20 (37.7%) did R0 resection including metastasectomy in stage 4 at the time of previous oxaliplatin treatment. Median time from last cycle of adjuvant FOLFOX to the first cycle of palliative oxaliplatin based chemotherapy was 31.5 months. Palliative oxaliplatin was given as second and third or later in 37 (69.8%) and 16 (30.2%) patients respectively. Median PFS and overall survival (OS) were 5.1 and 17.5 months. Response rate and disease control rate to palliative oxaliplatin based treatment were 17.0 % and 66.0%. Patients with both shorter interval from first oxaliplatin exposure to recurrence (<12 months) and shorter interval from recurrence to oxaliplatin re-exposure (<18 months) experienced shorter PFS significantly compared to those who did not (2.8 vs. 7.3m, p = 0.004). It was an independent predictive factor for PFS in addition to use of targeted agent in multivaviate analysis. Conclusions: In this study, re-treatment with oxaliplatin based chemotherapy after recurrence demonstrated modest clinical efficacy. Non-use of targeted agent and both shorter interval from first oxaliplatin exposure to recurrence and shorter interval from recurrence to oxaliplatin re-exposure are poor predictive factors for PFS.


2021 ◽  
pp. JCO.21.00306
Author(s):  
Kathleen N. Moore ◽  
Michael Bookman ◽  
Jalid Sehouli ◽  
Austin Miller ◽  
Charles Anderson ◽  
...  

PURPOSE To evaluate the addition of the humanized monoclonal antiprogrammed death ligand-1 (PD-L1) antibody, atezolizumab, to platinum-based chemotherapy and bevacizumab in newly diagnosed stage III or IV ovarian cancer (OC). METHODS This multicenter placebo-controlled double-blind randomized phase III trial (ClinicalTrials.gov identifier: NCT03038100 ) enrolled patients with newly diagnosed untreated International Federation of Gynecology and Obstetrics (FIGO) stage III or IV OC who either had undergone primary cytoreductive surgery with macroscopic residual disease or were planned to receive neoadjuvant chemotherapy and interval surgery. Patients were stratified by FIGO stage, Eastern Cooperative Oncology Group performance status, tumor immune cell PD-L1 staining, and treatment strategy and randomly assigned 1:1 to receive 3-weekly cycles of atezolizumab 1,200 mg or placebo (day 1, cycles 1-22), with paclitaxel plus carboplatin (day 1, cycles 1-6) plus bevacizumab 15 mg/kg (day 1, cycles 2-22), omitting perioperative bevacizumab in neoadjuvant patients. The co-primary end points were investigator-assessed progression-free survival and overall survival in the intention-to-treat and PD-L1–positive populations. RESULTS Between March 8, 2017, and March 26, 2019, 1,301 patients were enrolled. The median progression-free survival was 19.5 versus 18.4 months with atezolizumab versus placebo, respectively (hazard ratio, 0.92; 95% CI, 0.79 to 1.07; stratified log-rank P = .28), in the intention-to-treat population and 20.8 versus 18.5 months, respectively (hazard ratio, 0.80; 95% CI, 0.65 to 0.99; P = .038), in the PD-L1–positive population. The interim (immature) overall survival results showed no significant benefit from atezolizumab. The most common grade 3 or 4 adverse events were neutropenia (21% with atezolizumab v 21% with placebo), hypertension (18% v 20%, respectively), and anemia (12% v 12%). CONCLUSION Current evidence does not support the use of immune checkpoint inhibitors in newly diagnosed OC. Insight from this trial should inform further evaluation of immunotherapy in OC.


2006 ◽  
Vol 16 (Suppl 1) ◽  
pp. 47-53 ◽  
Author(s):  
H. Steed ◽  
A. M. Oza ◽  
J. Murphy ◽  
S. Laframboise ◽  
G. Lockwood ◽  
...  

The objective of this study is to compare progression-free survival (PFS) and overall survival (OS) of ovarian cancer patients treated with neoadjuvant chemotherapy and surgery to primary surgery and postoperative chemotherapy. Retrospective analysis from 1998 to 2003 of 116 patients with ovarian cancer was performed. Fifty women diagnosed by positive cytology received three cycles of carboplatin and paclitaxel. Thirty-six patients subsequently underwent cytoreductive surgery and completed three further cycles postoperatively. The OS and PFS were compared in 66 women treated with primary surgery and postoperative chemotherapy. A statistically significant difference was observed for OS (P= 0.03, HR = 1.85, CI = 1.06–3.23) and PFS (P= 0.04, HR = 1.61, CI = 1.03–2.53) favoring the primary surgery group. Due to the small numbers, age, grade, stage, pleural effusions, and histologic cell type were controlled for separately in the bivariate analyses. Controlling for stage made the results weaker. A matched subgroup survival analysis was performed on patients who had surgery following neoadjuvant chemotherapy. After matching for stage and grade and controlling age and pleural effusions (N= 28 matched pairs), there was no statistical difference for OS (P= 0.95, HR = 1.04, CI = 0.33–3.30) or PFS (P= 0.79, HR = 1.11, CI = 0.98–1.04). It is concluded that primary surgery should be considered in all patients. Neoadjuvant chemotherapy may be an alternative in a subset of women with the intent to also perform interval debulking.


1986 ◽  
Vol 4 (8) ◽  
pp. 1284-1284 ◽  
Author(s):  
P.F. Conte ◽  
M. Bruzzone ◽  
S. Chiara ◽  
M.R. Sertoli ◽  
M.G. Daga ◽  
...  

In the article by Conte et al, "A Randomized Trial Comparing Cisplatin Plus Cyclophosphamide Versus Cisplatin, Doxorubicin, and Cyclophosphamide in Advanced Ovarian Cancer" (Journal of Clinical Oncology 4:965–971, 1986), an error was made in the abstract on page 965 that altered the meaning of a sentence. The correct sentence appears below. After primary surgery, 125 patients with epithelial ovarian cancer (International Federation of Gynaecology and Obstetrics [FIGO] 1c + IIb + IIc = 22 patients, FIGO III = 82 patients, FIGO IV = 21 patients) were randomly allocated to receive PC (cisplatin 50 mg/m2 + cyclophosphamide 600 mg/m2 on day 1 every 28 days) or PAC (PC + doxorubicin 45 mg/m2).


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5590-5590
Author(s):  
R. O'Cearbhaill ◽  
Q. Zhou ◽  
A. Iasonos ◽  
R. A. Soslow ◽  
M. M. Leitao ◽  
...  

5590 Background: Although AIs are sometimes used in selected patients with uLMS, there are few data assessing the efficacy of AIs in this setting. Methods: A retrospective electronic medical record review of patients (pts) with uLMS treated with an AI at Memorial Sloan-Kettering Cancer Center between 1998–2008 was performed. The primary endpoint was progression free survival (PFS), defined as time from the start of AI until death, progression or last follow-up. PFS was estimated by Kaplan-Meier method. Best response using RECIST was also assessed. Results: 34 pts with advanced, measurable uLMS were treated with AIs. Median age was 53 yrs (range 35–74); median body mass index 28.1 kg/m2 (range 16.1–52.1); LMS grade low: 5, high: 29; hormone receptor status: 19 ER+, 9 ER-, 6 ER unknown, 9 PR+, 9 PR-, 16 PR unknown; low volume of disease (no lesion >2 cm): 19 pts(56%), high volume: 15 pts (44%). 23 pts (68%) had had prior chemotherapy (1 regimen: 29%, 2 regimens: 18%, 3 regimens: 15%, >4 regimens: 6%); 12 pts (35%) had had prior pelvic radiotherapy. AIs used were: letrozole 74% (9% with leuprolide if premenopausal), anastrozole 21%, exemestane 6%. Median PFS was 2.9 months (95% CI: 1.8–5.1). 8 pts (23.5%) had a PFS >6months. Among pts with ER or PR + uLMS, median PFS was 5months (95% CI: 1.8–9.4) versus 1.9months (95% CI: 0.9–3.2) with ER and PR negative uLMS. Best response was partial response in 3 pts (8.8%) (all of whom were ER+), stable disease in 12 (35%), and progressive disease in 19 (56%). Common toxicities were grade 1–2 asthenia (30%), hot flashes (30%), and arthralgias (27%). Conclusions: In this highly selected population of pts with uLMS AIs fail to achieve objective response. While relatively prolonged PFS was observed among ER and/or PR+ uLMS pts, in the absence of a no-treatment control group this outcome cannot be attributed solely to the activity of the AI treatment. No significant financial relationships to disclose.


2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 727-727
Author(s):  
Xin Yu ◽  
WeiWei Xiao ◽  
Rong Zhang ◽  
LuNing Zhang ◽  
Bo Qiu ◽  
...  

727 Background: To analyze the outcomes of neoadjuvant chemoradiotherapy (neoCRT) in the management of unresectable locally advanced adherent colon cancer (LAACC). Methods: 40 unresectable LAACC patients were identified from Sun Yat-Sen university cancer-center Database from October 2010 to December 2014. Unresectability was determined by multidisciplinary consultation (MDT) according to image examination or confirmed by exploratory laparotomy. NeoCRT followed by surgery and postoperative chemotherapy were given to these patients. There were 27 males and 13 females. Median age was 56 years old. The location of primary tumors were as sigmoid 31, descending colon 3, ascending colon 5, and cecum1, respectively. All the patients were treated with 45-50Gy/25F using 3D-CRT or IMRT, and concomitantly with capecitabine-based chemotherapy every 3 weeks. Surgery was scheduled 6-8 weeks after completion of radiotherapy. Results: A total of 40 patients completed neoCRT and 33 patients (82.5%) received radical resection for the locally diseases, with R0 and R2 resection in 30 and 3 patients, respectively. Seven patients were assessed as unresectable after neoCRT and 3 of them received only colostomy while the other 4 continued chemotherapy. Pathological complete response was documented in 8 patients (20.0%). Multivisceral resection was necessary in 15 patients (36.6%). Among the 33 patients underwent curative surgery, bladder invasion was noticed at diagnosis in 17 patient and bladder function was preserved in all these patients, with full bladder preserving approach in 6 and partial cystectomy in 11 patients. Grade-2 post-operative complications were observed in 4 patients (10.0%) with no 30-day mortality. Median follow-up was 26 months. For all the patients, the 3-year overall survival, local progression-free survival and progression-free survival were 70.8%, 88.2%, 74.5%, respectively. Conclusions: NeoCRT is an effective strategy for the treatment of unresectable LAACC, with high R0 resection rate, satisfactory organ preservation, good local control and acceptable treatment toxicity. NeoCRT in LAACC is worthy of further clinical research.


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