LAP2: Laparoscopy safe for staging in patients with uterine cancer

When compared with laparotomy, the use of laparoscopy for staging was feasible.

Laparoscopic surgical staging was safe and effective and demonstrated a modest advantage in quality of life in patients with uterine cancer, according to findings from two comparison studies.

Historically, surgical staging for uterine cancer has been performed via open laparotomy, but during the early 1990s, minimally invasive surgery was introduced. To evaluate outcomes of surgical staging by laparoscopy vs. laparotomy, two studies were conducted by the Gynecologic Oncology Group.

LAP-2 study findings promising

In the LAP-2 study, Joan L. Walker, MD, from the University of Oklahoma, and colleagues randomly assigned patients with clinical stage I to stage IIa uterine cancer to laparoscopy (n=1,696) or laparotomy (n=920) between May 1996 and September 2005. Laparotomy included hysterectomy, salpingo-oophorectomy, pelvic cytology and pelvic and para-aortic lymphadenectomy. The study results were published in the Journal of Clinical Oncology.

Conversion to laparotomy was required in 25.8% of patients assigned laparoscopy. Conversion was due to poor visibility (14.6%), cancer requiring laparotomy for resection (4.1%), excessive bleeding (2.9%) and other reasons (4.2%). Increasing age, increasing BMI and metastatic disease elevated the risk for failure to complete laparoscopy (P <.0001 for all).

The median operative duration was 204 minutes in the laparoscopy group compared with 130 minutes in the laparotomy group (P <.001). However, patients in the laparotomy group had more grade-2 or higher complications than patients in the laparoscopy group (21% vs. 14%; P<.001). The two methods had similar rates of intraoperative complications despite the longer operation time associated with laparoscopy.

The length of hospital stay was longer among patients assigned laparotomy vs. those assigned laparoscopy (94% vs. 52%; P<.0001). Para-aortic and pelvic lymph nodes were observed in 96% of laparotomy patients and 92% of laparoscopy patients (P<.001). Advanced surgical stage was detected in 17% of patients in both groups.

Recurrence patterns and survival results will be reported when the data are mature, according to the researchers.

“As long as we do not have these data, we cannot make a final judgment on the safety of endoscopy as primary surgical treatment in endometrial carcinoma,” Ignace Vergote, MD, PhD, head of the department of obstetrics and gynecology and gynecologic oncology, Catholic University of Leuven in Belgium, said in an accompanying editorial.

“Even if the survival and relapse outcomes were similar, we would need to evaluate carefully the advantages and disadvantages and the effect of large volume/expertise on the treatment outcome, especially in older and obese patients,” he said.

Improvements in QOL observed

The quality-of-life study was conducted by Alice B. Kornblith, PhD, from Dana-Farber Cancer Institute, Boston, and colleagues. This study enrolled the first 802 eligible patients from the Gynecologic Oncology Group’s trial of laparoscopy vs. laparotomy. Patient quality of life was assessed postsurgery at baseline; one, three and six weeks; and at six months. The results were also published in the Journal of Clinical Oncology.

In intent-to-treat analysis six weeks postsurgery, patients assigned laparoscopy reported higher Functional Assessment of Cancer Therapy–General scores (FACT-G; P=.001). They also reported better physical functioning (P=.006) and body image (P<.001); less pain (P<.001); and less pain interference with quality of life (P<.001). Patients assigned laparoscopy were also able to resume normal activities earlier (P=.003) and return to work earlier (P=.04).

The difference in average adjusted FACT-G scores between patients assigned laparoscopy and patients assigned laparotomy did not reach the minimally important difference of five points during the six-week period. Additionally, differences in body image and returning to work were modest.

Body image for the laparoscopic group was the only statistically significant quality-of-life measure that was different between the two groups at six months postsurgery (1.32 points; 95% CI, 0.61-2.04.)

“Although the FACT-G did not reach the minimally important difference between surgical groups and there were only modest statistically significant improvements in quality-of-life in laparoscopy compared with laparotomy patients in return to work and body image, the significant improvement in all quality of life variables, except for fear of recurrence in patients undergoing laparoscopy, provides some support for a quality-of-life advantage in the use of laparoscopy over laparotomy,” the researchers said.

For more information:

• Kornblith AB. J Clin Oncol. 2009;doi:10.1200/JCO.2009.22.3529.
• Vergote I. J Clin Oncol. 2009;doi:10.1200/JCO.2009.23.9822.
• Walker JL. J Clin Oncol. 2009;doi:10.1200/JCO.2009.22.3248.