A phase III trial of bevacizumab with IV versus IP chemotherapy for ovarian, fallopian tube, and peritoneal carcinoma: An NRG Oncology Study

Walker, Joan L.; Brady, Mark F.; DiSilvestro, Paul; Ds, Alberts; Zheng, Weiguang; Tewari, Krishnansu S.; Cohn, David E.; Powell, Matthew A.; Le, Linda Van; Rubin, Stephen C.; Davidson, Susan A.; Gray, Heidi J.; Waggoner, Steven; Myers, Tashanna; Aghajanian, Carol; Secord, Angeles Alvarez

doi:10.1016/j.ygyno.2016.04.535

Cited by 31 publications

(28 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…It was noted, however, that the PFS in the patients with no gross residual disease treated with IV/IP paclitaxel and IP cisplatin (33.8 months) did not approach the PFS seen in this group in trial GOG-172 (60.4 months). Interestingly, the median PFS for patients in our cohort who had no gross residual disease and received IP chemotherapy was 36.9 months, similar to that of GOG-252 and shorter than that of GOG-172 (31, 32). It has been postulated that the decreased dose of IP cisplatin may contribute to this discrepancy.…”

Section: Discussionsupporting

confidence: 61%

Cited rationale for variance in the use of primary intraperitoneal chemotherapy following optimal cytoreduction for stage III ovarian carcinoma at a high intraperitoneal chemotherapy utilization center

Schlappe

Mueller

Zivanovic

et al. 2016

Gynecologic Oncology

View full text Add to dashboard Cite

Objective Studies have demonstrated improved ovarian cancer survival with the administration of a combination of intravenous (IV) and intraperitoneal (IP) chemotherapy following optimal cytoreduction. Despite this, IV/IP chemotherapy is not uniformly used. In this retrospective cohort study, we assessed the documented reasons for giving IV-only chemotherapy. Methods All patients who had optimal primary cytoreductive surgery for stage III ovarian, fallopian tube, or primary peritoneal carcinoma, met eligibility criteria for GOG-172, and received primary chemotherapy at our institution between 2006 and 2013 were identified. Patients who received at least one cycle of adjuvant IV/IP therapy were included in the IP group. Patient characteristics, treatment information, and reason cited for not administering IP therapy were collected. Results Of the patients evaluated, 330 met inclusion criteria. The majority (n=261, 79%) received at least one IV/IP cycle (median, 6; range, 1–6), and 62% completed 6 cycles. The most common reason for giving IV-only therapy was postoperative status (i.e., delayed wound healing, performance status), accounting for 18 (26%) of the 69 IV-only patients (5% of the entire cohort). Other cited reasons were baseline comorbidities (15%) and IP port complications (12%). Receipt of ≥1 cycle of IP chemotherapy (HR 0.51; 95% CI, 0.32–0.80) and no gross residual disease (HR 0.47; 95% CI, 0.31–0.71) were associated with improved overall survival. Conclusion Potentially modifiable factors identified as leading to the use of IV-only chemotherapy were postoperative status and IP port complications, which if altered, could potentially lead to increased IP chemotherapy use.

show abstract

Section: Discussionsupporting

confidence: 61%

Cited rationale for variance in the use of primary intraperitoneal chemotherapy following optimal cytoreduction for stage III ovarian carcinoma at a high intraperitoneal chemotherapy utilization center

Schlappe

Mueller

Zivanovic

et al. 2016

Gynecologic Oncology

View full text Add to dashboard Cite

show abstract

“…and i.v. administration of similar doses of chemotherapy, the GOG 252 trial212 did not confirm PFS improvement with i.p. chemotherapy (presented at SGO 2016, still unpublished).…”

Section: Resultsmentioning

confidence: 97%

ESMO–ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease

Colombo

Sessa

Bois

et al. 2019

International Journal of Gynecological Cancer

358

468

View full text Add to dashboard Cite

The development of guidelines is one of the core activities of the European Society for Medical Oncology (ESMO) and European Society of Gynaecologial Oncology (ESGO), as part of the mission of both societies to improve the quality of care for patients with cancer across Europe. ESMO and ESGO jointly developed clinically relevant and evidence-based recommendations in several selected areas in order to improve the quality of care for women with ovarian cancer. The ESMO–ESGO consensus conference on ovarian cancer was held on April 12–14, 2018 in Milan, Italy, and comprised a multidisciplinary panel of 40 leading experts in the management of ovarian cancer. Before the conference, the expert panel worked on five clinically relevant questions regarding ovarian cancer relating to each of the following four areas: pathology and molecular biology, early-stage and borderline tumours, advanced stage disease and recurrent disease. Relevant scientific literature, as identified using a systematic search, was reviewed in advance. During the consensus conference, the panel developed recommendations for each specific question and a consensus was reached. The recommendations presented here are thus based on the best available evidence and expert agreement. This article presents the recommendations of this ESMO–ESGO consensus conference, together with a summary of evidence supporting each recommendation.

show abstract

“…One can also point to instances of major unexpected toxicities in phase I trials, 24,25 or t compelling surrogate evidence failed to translate into survival advantage. [26][27][28][29][30] One study often cited for the therapeutic position showed that patients with solid tumors who received higher doses of molecularly targeted agents had longer survival than patients who received lower doses. 31 However, because most phase I studies do not involve randomization and blinding, it is impossible to rule out that clinical investigators enroll hardier patients in high-dose groups and feebler patients in lower-dose cohorts (there is some evidence that such selective enrollment occurs 32 ).…”

Section: Evidencementioning

confidence: 99%

Is Participation in Cancer Phase I Trials Really Therapeutic?

Kimmelman

2017

JCO

View full text Add to dashboard Cite

Phase I trials are a key step in developing anticancer treatments. But because they administer unproven drugs to populations with life-threatening disease, their design and ethics are often debated. [1][2][3][4] In 1995, ASCO issued a policy declaring the importance of phase I studies as a treatment modality for patients with cancer who have advanced disease. ASCO revisited its policy in 2014. 5 The new policy amplifies the earlier position, reasserting two closely connected claims: first, that phase I cancer studies have therapeutic intent, and second, that they potentially "provide patients [who enroll with clinical benefit." 5(p1) In this article, I reinforce the first assertion and qualify the second. The therapeutic intent of many phase I cancer studies is attested to by the fact that most studies measure disease response, and many use designs aimed at maximizing clinical benefit. However, intent alone does not underwrite an actual therapeutic claim. The assertion that phase I trials offer a vehicle for pursuing cancer treatment (the "therapeutic position") rests on weak evidence and has counterproductive implications for human protection. It also erodes the ability of oncologists to rigorously evaluate new treatments and support evidence-based practice. Instead I propose a different view-the "research position"-that stresses the investigational orientation of phase I trials while accommodating exceptional cases and the therapeutic yearnings of patients and their caregivers. I close by suggesting how groups such as ASCO might refine their recommendations. EvidenceThe kernel of the therapeutic position expressed by ASCO is that investigators can and should present phase I trial participation as providing "the prospect of a direct medical benefit." 5(p2) Because direct benefit relates to the pharmacologic action of a drug, and because benefit in medicine is always measured against how patients would be treated otherwise, the therapeutic position is equivalent to saying that the risk/benefit for receiving experimental drugs in phase I trials is consistent with and possibly superior to standard of care.Proponents of this view draw on several streams of evidence. First, meta-analyses show objective response rates (ORRs) in the neighborhood of 5% and fatal toxicities of approximately 0.5% for monotherapy studies. [6][7][8] Proponents argue that these response rates

show abstract

A phase III trial of bevacizumab with IV versus IP chemotherapy for ovarian, fallopian tube, and peritoneal carcinoma: An NRG Oncology Study

Cited by 31 publications

References 0 publications

Cited rationale for variance in the use of primary intraperitoneal chemotherapy following optimal cytoreduction for stage III ovarian carcinoma at a high intraperitoneal chemotherapy utilization center

Cited rationale for variance in the use of primary intraperitoneal chemotherapy following optimal cytoreduction for stage III ovarian carcinoma at a high intraperitoneal chemotherapy utilization center

ESMO–ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease

Is Participation in Cancer Phase I Trials Really Therapeutic?

Contact Info

Product

Resources

About