Symptom burden and outcomes of patients with platinum resistant/refractory recurrent ovarian cancer: a reality check: results of stage 1 of the gynecologic cancer intergroup symptom benefit study.
BACKGROUND
The aim of chemotherapy in patients with platinum resistant ovarian cancer is palliation. Patients' experience of symptoms is not well documented, and the impact of treatment on symptoms has not been evaluated in clinical trials. We report symptom burden and treatment outcomes from stage 1 of the Gynecological Cancer Intergroup (GCIG) Symptom Benefit Study.


METHODS
One hundred twenty-six patients receiving palliative chemotherapy completed 5 validated health-related quality-of-life questionnaires before starting treatment and before each cycle. They also reported their expected and perceived benefits from treatment. Physicians documented the reasons for treatment and adverse events including symptoms at baseline and estimated the number of cycles of treatment that patients would receive.


RESULTS
Palliation was the major reason for chemotherapy. At baseline, all patients were symptomatic (almost 70% had ≥9 symptoms). Patients had high expectation of benefit from treatment. Only 41% of patients received the predicted number of cycles with most stopping early (≤2 cycles) due to progression, death, or adverse effects. Treatment was associated with significant toxicity, with discordance between patient report and physician grading. Although RECIST response rates were low (8.5%), 40% of the patients were reported to have had a clinical benefit and almost 50% of symptomatic patients also reported symptom improvement.


CONCLUSIONS
Patients had a complex array of symptoms and significant symptom burden, which was commonly the reason for treatment. Although chemotherapy improved symptoms in about half of the patients, many did not benefit and progressed rapidly. Our findings support research into the use of patient reported outcome measures to document symptoms, adverse events, and subjective benefit, both in clinical trials and in clinical practice, in this patient population. Our findings highlight the need to develop prognostic models to better select patients for treatment, and this is an aim of stage 2 of the GCIG Symptom Benefit Study.
*ANZGOG and NHMRC Clinical Trials Centre, University of Sydney and Prince of Wales Clinical School, University at New South Wales; †PoCoG, University of Sydney, Australia; ‡Princess Margaret Hospital, Toronto, Canada; and §University of Pittsburgh, School of Nursing, Pittsburgh, USA.
Michael Leonard
ML
Friedlander
Martin
M
Stockler
Rachel
R
O'Connell
Merryn
M
Voysey
Amit
A
Oza
Kim
K
Gillies
Heidi
H
Donovan
Julie
J
Martyn
Katrin
K
Sjoquist
Phyllis
P
Butow
Madeleine T
MT
King
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077216:Carcinoma, Ovarian Epithelial; D019008:Drug Resistance, Neoplasm; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000473:pathology; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010166:Palliative Care; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010984:Platinum / Q000494:pharmacology*; D011379:Prognosis; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
D010984:Platinum