Abstract

GOG 244 -The LymphEdema and Gynecologic cancer (LEG) study: The association between the gynecologic cancer lymphedema questionnaire (GCLQ) and lymphedema of the lower extremity (LLE)

Jeanne Carter a, *, Helen Q. Huang b, Jane Armer c, Jay W. Carlson d, Suzy Lockwood e, Susan Nolte f, 1, Bob R. Stewart g, James Kauderer b, Alan Hutson b, Joan L. Walker h, Aimee C. Fleury i, Albert Bonebrake j, John T. Soper k, Cara Mathews l, Oliver Zivanovic m, William Edwards Richards n, Annie Tan o, David S. Alberts p, Richard R. Barakat q, Lari Wenzel

Objective: To explore whether patient-reported lymphedema-related symptoms, as measured by the Gynecologic Cancer Lymphedema Questionnaire (GCLQ), are associated with a patient-reported diagnosis of lymphedema of the lower extremity (LLE) and limb volume change (LVC) in patients who have undergone radical surgery, including lymphadenectomy, for endometrial, cervical, or vulvar cancer on Gynecologic Oncology Group (GOG) study 244.

Methods: Patients completed the baseline and at least one post-surgery GCLQ and LVC assessment. The 20-item GCLQ measures seven symptom clustersdaching, heaviness, infection-related, numbness, physical functioning, general swelling, and limb swelling. LLE was defined as a patient self-reported LLE diagnosis on the GCLQ. LVC was measured by volume calculations based on circumferential measurements. A linear mixed model was fitted for change in symptom cluster scores and GCLQ total score and adjusted for disease sites and assessment time.

Results: Of 987 eligible patients, 894 were evaluable (endometrial, 719; cervical, 136; vulvar, 39). Of these, 14% reported an LLE diagnosis (endometrial, 11%; cervical, 18%; vulvar, 38%). Significantly more patients diagnosed versus not diagnosed with LLE reported 4-point increase from baseline on the GCLQ total score (p < 0.001). Changes from baseline were significantly larger on all GCLQ symptom cluster scores in patients with LLE compared to those without LLE. An LVC increment of >10% was significantly associated with reported general swelling (p < 0.001), heaviness (p ¼ 0.005), infection-related symptoms (p ¼ 0.002), and physical function (p ¼ 0.006).

Conclusions: Patient-reported symptoms, as measured by the GCLQ, discerned those with and without a patient-reported LLE diagnosis and demonstrated predictive value. The GCLQ combined with LVC may enhance our ability to identify LLE.

Main findings

• The primary aims of The LymphEdema and Gynecologic (LEG) Cancer Study were to prospectively estimate the incidence of LLE, and to identify risk factors associated with the development of LLE in patients undergoing surgery for gynecologic malignancy.
• The GCLQ assesses 20 symptoms associated with LLE, present within the past 4 weeks. Items are combined into seven symptom clusters of: heaviness (item 14), swelling (general) (items 8, 9, 20), swelling (limb) (items 18, 19), infection-related (items 10 [redness], 11 [blistering], 13 [increased temperature in leg]), aching (item 17), numbness (items 7, 12, 15, 16), and physical functioning (items 1e6). Each question is scaled as either 1 or 0 (with or without symptom, respectively).
• Limb volume change (LVC) was determined by circumferential measurements taken by trained professionals,
• By disease site, in patients with endometrial cancer, symptoms of aching (p ¼ 001), swelling (general) (p < 0.001), heaviness (p < 0.001), infection (p < 0.001), numbness (p < 0.001), and physical functioning (p < 0.001) were significantly different between those diagnosed with and without LLE; specifically, women with LLE were more symptomatic. The symptom cluster of swelling in the leg (p ¼ 0.03) had a mild group difference. For the cervical cancer group, symptoms of swelling (general) (p < 0.001), heaviness (p = 0.006), swelling in the leg (p = 0.009), and numbness (p =0.013) showed a strong significant difference, and a marginal difference for infection (p = 0.046). For the vulvar cancer group, symptoms of swelling (general) (p < 0.001), heaviness (p(p = 0.006), swelling in the leg (p_ficantly different. = 0.01), and numbness < 0.001) were significantly different.
• This national cooperative group study sought to assess whether patient self-reported lymphedema symptoms (as measured by the GCLQ) were associated with the development of LLE. This PRO was able to distinguish between those with and without a formal LLE diagnosis (as reported by patients) and related LVC (estimate of LLE). The results also support findings that cluster symptoms are associated with the development of LLE as measured by LVC and patient-reported LLE.
• In this study, the GCLQ was able to identify patients reporting a diagnosis of LLE and was also able to demonstrate a predictive value of PRO LLE symptom assessment in patients at risk for developing LLE by LVC assessment.
• The GCLQ is a simple and feasible screening tool that could be offered to patients both pre-and post-treatment to monitor for potential changes that need further evaluation or referral.
• This is the largest prospective trial examining LLE occurrence in women newly diagnosed and treated for gynecologic cancer over a 2-year period.