Abstract
During the recent years CHOP-14 based chemotherapy in combination with the monoclonal anti-CD20 antibody Rituximab has become the standard choice of treatment for non-localized, poor risk Diffuse Large B-Cell Lymphoma (DLBCL). The German NHL-B1 and -B2 trials have demonstrated favourable efficacy and safety. We, and others, have observed a relatively high frequency of severe toxicity, infections and malnutrition in very high-risk patients, responsible for increased morbidity during treatment. To our knowledge, no studies have evaluated QoL in patients treated with CHOP-14 based chemotherapy. The aim of this study was to prospectively evaluate whether QoL was affected in DLBCL patients treated with dose-dense CHOP-based chemotherapy.
Health-related QoL was assessed using the validated EORTC QLQ-C30 (version 3) questionaire, which is a 30-item instrument developed specifically for use in international clinical cancer research.
26 patients with DLBCL (22 (85%) de novo and 4 (15%) transformed follicular lymphoma) were included. Median age was 59 years (27–78), 18 (69%) had CS III/IV disease, 14 (54%) extranodal involvement, 19 (73%) elevated LDH, 10 (39%) a Performance Score ≥2, i.e. 13 (50%) presented with IPI 3–5 disease. Furthermore, 7 (27%) had bone marrow involvement, 13 (50%) bulky disease and 18 (69%) B-symptoms. All patients received 6 or 8 cycles of CHOP-14 based chemotherapy, and 17 of the patients received Rituximab at day 1 of each cycle. The patients completed the QLQ-C30 questionaire at four predefined timepoints according to chemotherapy treatment:
pre-treatment,
mid-treatment (14 days after the 4th cycle),
14 days post-treatment and
3 months post-treatment.
Patient scores were compared to scores from an age- and gender-adjusted reference population, and separately analyzed over time (using non-parametric statistical analyzes). At pre-treatment only global health status (p=0.008) and role functioning (p=0.049) were impaired compared to the reference population. During treatment, global health status (p=0.008), physical functioning (p<0.001) and role functioning (p=0.003) were significantly decreased, and fatigue (p<0.001), dyspnoea (p=0.028) and appetite loss (p=0.007) significantly increased. All six scales were normalized three months posttreatment. At three months post-treatment the patients generally scored equal with the reference population, and in fact significantly higher in emotional and social functioning, and significantly lower in all symptom scales except fatigue.
EORTC QLQ-C30 scores (treatment vs. pre-treatment)
| QoL-scales . | Pre-treatment . | Mid-treatment . | 14 days post-treatment . | 3 months post-treatment . |
|---|---|---|---|---|
| . | (N=26) . | (N=26) . | (N=23) . | (N=24) . |
| . | Mean . | Mean differences (95%CI) . | ||
| Global health status/QoL | ||||
| Global health status/QoL | 60 | −4 (−16;−8) | −9 (−20;2) | +10 (0;21) |
| Functional scales | ||||
| Physical functioning | 79 | −12 (−22;−2) | −17 (−28;−6) | +1 (−8;9) |
| Role functioning | 63 | −19 (−36;−2) | −20 (−38;−3) | +7 (−9;23) |
| Emotional functioning | 74 | +7 (0;14) | +10 (0;19) | +16 (7;24) |
| Cognitive functioning | 85 | −8 (−16;1) | −1 (−10;8) | −1 (−11;10) |
| Social functioning | 81 | −3 (−13;−8) | −3 (−14;8) | +8 (−5;21) |
| Symptom scales/items | ||||
| Fatigue | 41 | +15 (2;28) | +14 (1;26) | −12 (−27;6) |
| Nausea and vomiting | 6 | +4 (−4;13) | −1 (−9;6) | −6 (−14;1) |
| Pain | 19 | −1 (−12;10) | +1 (−8;11) | −4 (−19;11) |
| Dyspnoea | 24 | +8 (−6;21) | +3 (−12;18) | −11 (−26;4) |
| Insomnia | 31 | −4 (−18;11) | −12 (−25;2) | −13 (−27;2) |
| Appetite loss | 24 | +6 (−10;23) | +10 (−11;31) | −17 (−33;−1) |
| Constipation | 12 | +4 (−11;18) | −4 (−17;8) | −10 (−19;0) |
| Diarrhoea | 5 | +14 (3;25) | +13 (3;23) | +8 (−1;18) |
| Financial difficulties | 9 | +3 (−7;12) | +3 (−7;13) | +1 (−13;15) |
| QoL-scales . | Pre-treatment . | Mid-treatment . | 14 days post-treatment . | 3 months post-treatment . |
|---|---|---|---|---|
| . | (N=26) . | (N=26) . | (N=23) . | (N=24) . |
| . | Mean . | Mean differences (95%CI) . | ||
| Global health status/QoL | ||||
| Global health status/QoL | 60 | −4 (−16;−8) | −9 (−20;2) | +10 (0;21) |
| Functional scales | ||||
| Physical functioning | 79 | −12 (−22;−2) | −17 (−28;−6) | +1 (−8;9) |
| Role functioning | 63 | −19 (−36;−2) | −20 (−38;−3) | +7 (−9;23) |
| Emotional functioning | 74 | +7 (0;14) | +10 (0;19) | +16 (7;24) |
| Cognitive functioning | 85 | −8 (−16;1) | −1 (−10;8) | −1 (−11;10) |
| Social functioning | 81 | −3 (−13;−8) | −3 (−14;8) | +8 (−5;21) |
| Symptom scales/items | ||||
| Fatigue | 41 | +15 (2;28) | +14 (1;26) | −12 (−27;6) |
| Nausea and vomiting | 6 | +4 (−4;13) | −1 (−9;6) | −6 (−14;1) |
| Pain | 19 | −1 (−12;10) | +1 (−8;11) | −4 (−19;11) |
| Dyspnoea | 24 | +8 (−6;21) | +3 (−12;18) | −11 (−26;4) |
| Insomnia | 31 | −4 (−18;11) | −12 (−25;2) | −13 (−27;2) |
| Appetite loss | 24 | +6 (−10;23) | +10 (−11;31) | −17 (−33;−1) |
| Constipation | 12 | +4 (−11;18) | −4 (−17;8) | −10 (−19;0) |
| Diarrhoea | 5 | +14 (3;25) | +13 (3;23) | +8 (−1;18) |
| Financial difficulties | 9 | +3 (−7;12) | +3 (−7;13) | +1 (−13;15) |
Our study indicates, that disease-related symptoms are infrequent in these poor-risk DLBCL patients (according to pre-treatment scores), and that treatment-related symptoms are short-lived. QoL is affected during CHOP-14 based chemotherapy, but only temporarily. The treatment regimen is therefore applicable and safe with regard to QoL in this setting.
Disclosures: No relevant conflicts of interest to declare.
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