New lesions versus growth of existing disease: Does it impact prognosis? ASCO Meeting Abstract

Note: this study concerns the clinical criteria for evidence of progressive/new disease 

Conclusions:

In 9,741 (patients), survival after development of new lesions as the sole reason for progression did not significantly differ from patients with other reasons of PD (progressive disease). These findings give further validation to the use of new lesions as a classifier of PD according to established criteria. (RECIST)

Background:

Clinical trials use established criteria (RECIST or WHO) to determine objective tumor behavior on therapy. Participants are labeled to have progressive disease (PD) and are taken off study if they meet specific parameters of increase in size of their known lesions, but can also be labeled as PD if they develop new lesions without meeting criteria for progression in known lesions. To determine whether there are outcome disparities among these patients, we explored survival differences by reason of progression among patients who developed PD on study using data from the phase III Intergroup trial N9741 which compared IFL, FOLFOX4, and IROX as first-line therapy in advanced colorectal cancer (Goldberg JCO 2004).

Improved 5-year disease-free survival for FIGO stage I epithelial ovarian cancer patients without tumor rupture during surgery

Abstract

Objective.

To investigate the impact of perioperative capsule rupture on disease-free survival (DFS) and cancer-specific survival (CSS) in patients with FIGO stage I epithelial ovarian cancer (EOC I).

Methods.

This prospective population-based study enrolled all 279 patients with EOC I diagnosed in Norway between 2002 and 2004. All patients underwent primary surgery. The data were collected from notification reports to the Norwegian Cancer Registry and included medical, surgical and histopathological records. Kaplan–Meier plots were used to show differences in DFS and CSS. Cox regression analyses were used to show the effect of prognostic factors on survival, expressed as hazard ratios (HRs).

Results.

Significantly more patients in the capsule rupture group (Cr group) had clear cell tumors (28%) than in the FIGO stage IA and IB (AB group: 14%) groups, and the FIGO stage IC (C group: 17%; p < 0.05) group. Despite adjuvant chemotherapy (AC), these patients had a poor 5-year DFS, 94% in the non-AC group and 81% in the AC group (p < 0.01).
After five years of follow-up, there was a lower DFS among patients in the Cr group (79%) and the C group (81%), compared with patients in the AB group (91%; p < 0.05). Independent prognostic factors at the time of diagnosis were grade, histological type, ascites, adhesions, performance status, CA125 and DNA ploidy.
After correcting for the four most important prognostic factors (grade, histological type, ascites, and DNA ploidy), the HR for recurrence was 4.0 (95% CI 1.3–12.7; p < 0.05) for the Cr group and 1.8 (95% CI 0.5–6.1; p = 0.3) for the C group, compared with the AB group.

Conclusions.

Improvement was observed in the 5-year DFS for EOC I patients without tumor rupture during surgery compared with those with tumor rupture. Since AC did not improve the long-term DFS and CSS rates, it is of utmost importance that surgeons avoid tumor rupture during surgery.

Research Highlights

► Impact of perioperative capsule rupture on DFS and CSS in stage I epithelial ovarian cancer.
► The study was prospective and population-based.
► Stage I epithelial ovarian cancer without tumor rupture during surgery has improved at the 5-year DFS.