Cytoreductive Surgery With or Without HIPEC After Neoadjuvant Chemotherapy in Ovarian Cancer: A Phase 3 Clinical Trial

Campos, Pedro Antonio Cascales; Alida, González; Elena, G.; Rocío, González Sánchez; Jerónimo, Martínez García; Alonso-Romero, José Luis; Aníbal, Nieto Díaz; Francisco, Barceló Valcárcel; Jesús, Gómez Ruiz Álvaro; Pablo, Ramírez Romero; J, Gil

doi:10.1245/s10434-021-11087-7

Cited by 62 publications

(42 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Those results have been supported by a very recently published prospective Phase II trial [29], which analyzed 70 IDS patients, 50% of them randomized to receive HIPEC with cisplatin 75 mg/m 2 . The results confirmed an improved PFS (primary endpoint of the study) in the HIPEC treated patients (18 months in experimental group vs 12 months in the control group; p = 0.038) with comparable morbidity (p > 0.05) and quality of life evaluation.…”

Section: Hipec In Interval Debulking Surgerymentioning

confidence: 76%

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Management of Advanced Ovarian Cancer. A Literature Review

Ghirardi¹,

Trozzi²,

Giudice³

et al. 2022

EJGO

View full text Add to dashboard Cite

The rationale behind the use of hyperthermic intraperitoneal chemotherapy (HIPEC) after cytoreductive surgery is the association between pharmacological activity of chemotherapy delivered to the peritoneal cavity with the enhanced cytotoxic effect of hyperthermia. Data on the efficacy of HIPEC in the primary debulking surgery (PDS) setting are still controversial and limited by the small sample size of most of the studies, the inclusion of different treatment settings and chemotherapy regimens. Among the ongoing prospective trials, only the OVHIPEC-2 trial is investigating exclusively patients submitted to PDS ± HIPEC with cisplatin 100 mg/m 2 and results are expected by 2026. On the interval debulking surgery (IDS) setting high quality data are coming from the result of the OVHIPEC-1 trial, which demonstrated a survival advantage of nearly 4 months in median progression-free survival (PFS) (14.2 months vs. 10.7 months; p = 0.003) and almost 12 months in median overall survival (OS) (45.7 months vs. 33.9 months; p = 0.02) for HIPEC treated patients (cisplatin 100 mg/m 2 ) compared to no-HIPEC group, with comparable morbidity. However, due to some criticisms raised to the results of OVHIPEC-1 trial, the ESMO-ESGO guidelines recommended not to consider HIPEC as standard therapy until results from ongoing randomized control trials (RCTs) are provided. On the contrary, for the National Comprehensive cancer network (NCCN) guidelines HIPEC can be considered at the time of IDS. Similarly, data supporting the role of HIPEC in association with surgery in case of recurrent disease appear to be controversial in terms of patients and selection and intraperitoneal chemotherapy regimen. Indeed, despite the positive results coming from a prospective randomized trial, they appear to be biased by the inclusion of both platinum sensitive and resistant disease and the lack of information on PFS. Those results are in contrast with data coming from another prospective trial, which failed to demonstrate a survival gain of recurrent ovarian cancer patients treated with secondary cytoreductive surgery + HIPEC with carboplatin (800 mg/m 2 for 90 min) compared to women submitted to cytoreduction only. Again, in this subgroup of patients data of ongoing RCTs are awaited to assess the impact on survival of HIPEC administration in case of recurrent disease.

show abstract

Section: Hipec In Interval Debulking Surgerymentioning

confidence: 76%

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Management of Advanced Ovarian Cancer. A Literature Review

Ghirardi¹,

Trozzi²,

Giudice³

et al. 2022

EJGO

View full text Add to dashboard Cite

show abstract

“…Numerous worldwide medical centers have incorporated CRS with peritonectomy procedures associated to HIPEC to treat peritoneal carcinomatosis, making this technique controversial when the carcinomatosis originates from the colon [ 45 , 46 ]; however, nowadays such treatment is the standard care in pseudomyxoma peritonei [ 47 , 48 ] and mesothelioma [ 49 ]. Although the standard treatment of ovarian carcinomatosis is not CRS-HIPEC [ 1 , 2 ], evidence of its use is growing after recent publications of RCTs [ 50 , 51 , 52 , 53 ] and meta-analyses [ 54 , 55 ].…”

Section: Discussionmentioning

confidence: 99%

“…For primary EOC, better disease-free survival (DFS) rates and OS were observed in patients treated with neoadjuvant chemotherapy (NAC) followed by interval CRS-HIPEC, compared to those treated with NAC followed by interval CRS alone [ 51 , 52 , 53 ].…”

Section: Discussionmentioning

confidence: 99%

The Role of Intraperitoneal Intraoperative Chemotherapy with Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis from Ovarian Cancer—Hyperthermia versus Normothermia: A Randomized Controlled Trial

Casado-Adam

Rodríguez‐Ortiz

Rufián-Peña

et al. 2022

JCM

View full text Add to dashboard Cite

Background: The treatment of ovarian carcinomatosis with cytoreductive surgery and HIPEC is still controversial. The effect and pharmacokinetics of the chemotherapeutics used (especially taxanes) are currently under consideration. Methods: A phase II, simple blind and randomized controlled trial (NTC02739698) was performed. The trial included 32 patients with primary or recurrent ovarian carcinomatosis undergoing cytoreductive surgery (CRS) and intraoperative intraperitoneal chemotherapy with paclitaxel (PTX): 16 in hyperthermic (42–43 °C) and 16 in normothermic (37 °C) conditions. Tissue, serum and plasma samples were taken in every patient before and after intraperitoneal chemotherapy to measure the concentration of PTX. To analyze the immunohistochemical profile of p53, p27, p21, ki67, PCNA and caspase-3 and the pathological response, a scale of intensity and percentage of expression and a grouped Miller and Payne system were used, respectively. Perioperative characteristics and morbi-mortality were also analyzed. Results: The main characteristics of patients, surgical morbidity, hemotoxicity and nephrotoxicity were similar in both groups. The concentration of paclitaxel in the tissue was higher than that observed in plasma and serum, although no statistically significant differences were found between the two groups. No statistically significant association regarding pathological response and apoptosis (caspase-3) between both groups was proved. There were no statistically significant differences between the normothermic and the hyperthermic group for pathological response and apoptosis. Conclusions: The use of intraperitoneal PTX has proven adequate pharmacokinetics with reduction of cell cycle and proliferation markers globally without finding statistically significant differences between its administration under hyperthermia versus normothermia conditions.

show abstract

“…5 For patients with ovarian cancer, there is also increasing evidence suggesting that the addition of HIPEC is associated with improvements in survival. [6][7][8] Previously, we reported that the use of HIPEC in the neoadjuvant setting is tolerable and feasible, and named the corresponding strategy neoadjuvant HIPEC (NHIPEC). 9 However, the efficacy of NHIPEC remains unknown.…”

Section: Introductionmentioning

confidence: 99%

“…The rationale and theoretical benefits of HIPEC for patients with peritoneal carcinomatosis were acknowledged decades ago 5 . For patients with ovarian cancer, there is also increasing evidence suggesting that the addition of HIPEC is associated with improvements in survival 6–8 . Previously, we reported that the use of HIPEC in the neoadjuvant setting is tolerable and feasible, and named the corresponding strategy neoadjuvant HIPEC (NHIPEC) 9 .…”

Section: Introductionmentioning

confidence: 99%

Effects of neoadjuvant hyperthermic intraperitoneal chemotherapy on chemotherapy response score and recurrence in high‐grade serous ovarian cancer patients with advanced disease: A multicentre retrospective cohort study

Liang

et al. 2022

BJOG

View full text Add to dashboard Cite

Objective To investigate whether the combination of neoadjuvant hyperthermic intraperitoneal chemotherapy (NHIPEC) plus intravenous neoadjuvant chemotherapy (IV NACT) has superior efficacy to IV NACT alone. Design Retrospective cohort study. Setting Two tertiary referral university hospitals. Population Patients with ovarian cancer who received NACT‐interval debulking surgery (IDS) between 2012 and 2020. Methods The tumour response to NACT was evaluated with the chemotherapy response score (CRS) system. Survival outcomes were compared. Main outcome measures CRS 3, progression‐free survival (PFS), and overall survival (OS). Results In total, 127 patients were included, and 46 received NHIPEC plus IV NACT. The addition of NHIPEC was independently associated with an increased likelihood of CRS 3 (p = 0.033). Patients who received NHIPEC + IV NACT had significantly improved PFS compared with those who received IV NACT alone (median PFS: 22 versus 16 months, p < 0.001). The use of NHIPEC was identified as an independent predictor of PFS (p < 0.0001). OS did not differ significantly between treatment groups (p = 0.062), although a trend favouring NHIPEC was noted. Incidence of grade 3–4 adverse events and the surgical complexity score of IDS were similar between the two groups. Conclusions Compared with IV NACT alone, the combination of NHIPEC and IV NACT resulted in improved tumour response and longer PFS. The addition of NHIPEC did not increase the risk of adverse effects or affect the complexity of IDS.

show abstract

Cytoreductive Surgery With or Without HIPEC After Neoadjuvant Chemotherapy in Ovarian Cancer: A Phase 3 Clinical Trial

Cited by 62 publications

References 23 publications

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Management of Advanced Ovarian Cancer. A Literature Review

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Management of Advanced Ovarian Cancer. A Literature Review

The Role of Intraperitoneal Intraoperative Chemotherapy with Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis from Ovarian Cancer—Hyperthermia versus Normothermia: A Randomized Controlled Trial

Effects of neoadjuvant hyperthermic intraperitoneal chemotherapy on chemotherapy response score and recurrence in high‐grade serous ovarian cancer patients with advanced disease: A multicentre retrospective cohort study

Contact Info

Product

Resources

About