Background: Patient-reported outcomes (PROs) of quality of life (QOL) during chemotherapy involving lung cancer are very important for the medical staffs. Patients’ satisfaction and healthy changes were evaluated by the patient-self assessment. Materials and Methods: From July 2007 to April 2008, a total of 19 patients received chemotherapy. The QOL data were collected by using the QOL questionnaire for cancer patients treated with anticancer drugs (QOL-ACD) and the anti-aging QOL assessment (AA-QOL). The AA-QOL contained 51 items: 30 of physical and 21 of mental symptoms of the elderly and the aging population. The patients replied to the questions at two different times, i.e., at pre-chemotherapy (baseline) and at post-chemotherapy (2 weeks after the chemotherapy). Results: Regarding the hematological toxicities, for the grade 3/4 toxicities, there were 12 neutropenia (12/19, 63.2%) and 3 thrombocytopenia (3/19, 15.8%). For the grade 3 febrile neutropenia, there were 5 cases (5/19, 26.3%). Regarding the non-hematological toxicities, there was no grade 3 and grade 4 toxicities. Based on the outcomes of the QOL-ACD, the three items (“physical condition”, “social attitude”, and “overall QOL”) at post-chemotherapy became significantly worse compared to the baseline. Regarding the outcomes of the AA-QOL, 4 items of physical symptoms (“thirst”, “anorexia”, “early satiety”, and “diarrhea”) became significantly worse compared to the baseline. Regarding the mental symptoms, 2 items (“nothing to look forward in life” and “a sense of uselessness”) became significantly worse compared to the baseline. Conclusion: Regarding the PROs of the QOL during the chemotherapy term, both the physical and mental symptoms had become worse. To clarify the changes in the QOL during chemotherapy is very important for multidisciplinary teamwork, which should play the role of providing the appropriate cares and treatment as patient-support.
Lung cancer is one of the most common malignancies and remains the leading cause of cancer-related deaths in Europe and the USA [
Although platinum-based doublets involving newer agents, such as docetaxel, paclitaxel, gemcitabine, vinorelbine, and irinotecan, are the standard first-line chemotherapy for most patients with advanced NSCLC [
More recent randomized trials of adjuvant cisplatin-based chemotherapy have shown only a marginally better compliance despite considerable improvements in the supportive care medications available over the past decade. North American [
The World Health Organization defined the QOL as “individual” perceptions of their position in life in the context of their culture and value systems in which they live and in relation to their goal, expectation, standards and concerns” [
However, regarding the HR-QOL in the chemotherapy of lung cancer, it is important to assess the clinical outcome based on the patient’s aspect. There are very few studies about the QOL, especially about patient-reported outcomes (PROs). It is also difficult for doctors and nurses to evaluate the patients’ QOL as comprehensive and objective indicators. PROs include areas of the HR-QOL, but also broader concepts such as patient satisfaction with care and treatment.
We previously reported the PRO of the surgery of lung cancer by an evaluation based on the questionnaires of the anti-aging quality of life (AA-QOL) and EORTC-C30 QLQ [
The aim of the present study is to clarify the patient’s satisfaction and healthy changes of the patients receiving chemotherapy for lung cancer, which is an evaluation to be performed by the patient’s self-assessment. We did not use the famous and the most world-widely-used EORTC QLQ questionnaire survey in this study. However, we used two patient-reported questionnaire surveys of the QOL; one is the QOL questionnaire for cancer patients treated with anticancer drugs (QOL-ACD), which consists of four domains (functional, physical, mental, and psychosocial), and a global face scale developed as a generic questionnaire for Japanese cancer patients undergoing chemotherapy [
This study was approved by the University of Miyazaki Hospital Clinical Research Ethics Board. The procedures used in this study were in accordance with the Helsinki Declaration. From July 2007 to April 2008, a total of 19 patients, who received neoadjuvant therapy, adjuvant therapy, and intensive chemotherapy for recurring cases of the CBDCA-GEM or CBDCA-PTX or CDDP + DOC doublet combinations and DOC monotherapy. The characteristics of the 19 patients entered in this study are summarized in
Pathological stage diagnosed with IB to IV, Eastern Cooperative Oncology Gro- up Performance Status of 0, 1 or 2, adequate bone marrow function (total leukocyte count ≥4.0 × 109/ L, hemoglobin concentration ≥10.0 g/dl, platelet count ≥100 × 109/L), adequate liver and renal function (serum transaminase ≤2 times normal value; serum creatinine ≤1.5 times normal value), partial pressure of arterial oxygen (paO2) ≥60 torr, past history of severe allergic reaction to drugs, interstitial pneumonia identified by computed-tomography of chest, cirrhosis, or other serious complications, such as uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure, uncontrolled diabetes mellitus or hy- pertension, and uncontrolled massive pleural effusion or ascites, no postoperative complications, able to undergo first course treatment in an inpatient setting within 4 to 8 weeks after surgery, and written informed consent.
Gender | Male/Female | 13/6 |
---|---|---|
Age (year) | Mean ± SD | 66.2 ± 10.1 |
Range | 44 - 86 | |
ECOG-PS | 0/1 | 19/0 |
Surgery | Lobectomy | 19 |
Histology | Adenocarcinoma | 17 |
Squamous cell carcinoma | 2 | |
Pathological stage | IIA | 2 |
IIIA | 9 | |
IIIB | 3 | |
IV | 5 | |
Chemotherapy | Neoadjuvant therapy | 3 |
Adjuvant therapy | 11 | |
Intensive chemotherapy for recurrence | 5 | |
Regimen | GEM + CBDCA | 13 |
PTX + CBDCA | 3 | |
DOC + CDDP | 2 | |
DOC | 1 | |
Planned cycles | 2/3/4 cycles | 8/3/8 |
Received cycles | 2/3/4 cycles | 8/3/8 |
Compliance | Dose reduction | 5/19 (26.3%) |
Delayed | 1/19 (5.3%) | |
Response evaluation | Partial response | 3 (37.5%, 3/8) |
Stable disease | 5 (62.5%, 5/8) | |
Toxicities | ≥Grade 3/4 | 14/19 (73.7%) |
ECOG-PS: Eastern Cooperative Oncology Group Performance Status, GEM: Gemcitabine, CBDCA: Carboplatin, PTX: Paclitaxel, CDDP: Cisplatin, DOC: Docetaxel.
All patients received one protocol from the prepared four treatment regimens by the attending doctors’ direction and/or patients’ favorable selection depending on the regimen’s toxicities. The body surface area was calculated using the DuBois equation. The carboplatin dosage calculation was based on the glome- rular filtration rate according to the Calvert formula [
Gemcitabine (Gemzar®, Eli Lilly Japan K.K., Kobe, Japan) was administered at a dose of 1000 mg/m2 on days 1 and 8, and carboplatin (Paraplatin®, Bristol-Myers K.K., Tokyo, Japan) with the target dose of area under the curve (AUC) of 4 on day 8 every 28 days. Premedication was intravenously performed by drip infusion of 100 ml of isotonic sodium chloride solution containing 8 mg of dexamethasone sodium phosphate and 3 mg of granisetron hydrochloride. On days 1 and 8, the intravenous (i.v.) administration of 1000 mg/m2 gemcitabine mixed in 100 ml of isotonic sodium chloride solution was performed by drip infusion for 30 minutes. On day 8, carboplatin with the calculated dose of the AUC mixed in 250 ml of a 5% glucose solution was administered for 1 hour, following the drip infusion of gemcitabine.
Paclitaxel (Paclitaxel®, Bristol-Myers K.K., Tokyo, Japan) was administered at a dose of 70 mg/m2 on days 1, 8 and 15, and carboplatin (Paraplatin®, Bristol- Myers K.K., Tokyo, Japan) with the target dose of AUC of 5 on day 1 every 28 days. As a premedication, 50 mg of diphenhydramine hydrochloride was intravenously infused. The drip infusion of 50 ml of an isotonic sodium chloride solution containing 8 mg of dexamethasone sodium phosphate, 50 mg of ranitidine hydrochloride and 10 mg of azasetron hydrochloride was performed. After the administration of seventy mg/m2 of paclitaxel in 250 ml of a 5% glucose solution for over 1 hour, carboplatin with the calculated dose of the AUC mixed in 250 ml of a 5% glucose solution was intravenously infused for 1 hour.
Docetaxel (Taxotere®, Sanofi K.K., Tokyo, Japan) was administered at a dose of 60 mg/m2 on day 1, and cisplatin (Platosin®, Phizer Japan, Inc., Tokyo, Japan) on day 1 every 28 days. The drip infusion of 100 ml of an isotonic sodium chloride solution containing 8 mg of dexamethasone sodium phosphate and 3 mg of granisetron hydrochloride was performed. After the administration of 60 mg/m2 of docetaxel in 250 ml of a 5% glucose solution for over 1 hour, 80 mg/m2 of cisplatin in 500 ml of an isotonic sodium chloride solution was intravenously infused for 2 hours. As hydration, drip infusions of 500 ml of an isotonic sodium chloride solution for over 2 hours, 500 ml of a 5% glucose solution for over 2 hours, and 500 ml of a maintenance solution with electrolyte for over 2 hours were performed. The drip infusion of 300 ml of a 20% of D-mannitol for over 1 hour was performed. A 20 mg amount of furosemide was intravenously injected.
Docetaxel (Taxotere®, Sanofi K.K., Tokyo, Japan) was administered at a dose of 60 mg/m2 on day 1 every 21 days. The drip infusion of 100 ml of an isotonic sodium chloride solution containing 8 mg of dexamethasone sodium phosphate and 3 mg of granisetron hydrochloride was performed. The drip infusion of 250 ml of an isotonic sodium chloride solution containing 60 mg/m2 of docetaxel (Taxotere®, Sanofi K.K., Tokyo, Japan) for over 1 hour was performed.
The exclusion criteria included serious infection, fever (≥38˚C), impairments of an organ function (bone marrow, central nervous and cardiovascular system, liver, kidneys, interstitial pneumonia, and disseminated intravascular coagulation), patient’s refusal and attending doctor’s decision.
Prior to receiving the chemotherapy, all patients provided a complete medical history and underwent a physical examination. Patients were monitored weekly throughout the treatment by physical examination, recording of toxic effects, complete blood cell counts, and blood chemistry. These patients were examined for their background characteristics, adverse events, treatment compliance and relapse-free survival. Adverse events (AE) were evaluated for 4 weeks after the completion of the chemotherapy according to the Common Terminology Criteria for Adverse Events Version. 3.0 (CTCAE v3.0). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each adverse event based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; grade 5, Death related to AE. Grade 3/4 thrombocytopenia (grade 3, <50.0 ? 25.0 × 109/l; grade 4, <25.0 × 109/l) and grade 1/2 alopecia (grade 1, thinning or patchy; grade 2, complete) were defined.
The QOL data were collected using questionnaires from the QOL questionnaire for cancer patients treated with anticancer drugs (QOL-ACD) and the Anti-ag- ing Quality-of-Life Assessment (AA-QOL). The questionnaires of the QOL- ACD and the AA-QOL were used to obtain the patient-centered QOL during the chemotherapy treatment period. The patients replied to the questionnaires at different times. i.e., before and after chemotherapy, which was at the pre-che- motherapy (baseline) and at the post-chemotherapy (2 weeks after the chemotherapy). The obtained data of these scores at the pre-chemotherapy and the post-chemotherapy times were averaged and compared between the two groups, of which the changes were represented as the second evaluation of the QOL.
The QOL questionnaire for cancer patients treated with anticancer drugs (QOL-ACD), which consists of four domains (functional, physical, mental, and psychosocial) and a global face scale, was developed as a generic questionnaire for Japanese cancer patients undergoing chemotherapy [
Observation of improvement in the QOL was used by a common interview sheet. At the baseline and after surgery, any improvement in the QOL, i.e., “phy- sical symptoms” and “mental symptoms” as subjective symptoms, were evalu- ated using a five-point scale (1-point: absolutely none; 2-point: almost not; 3- point: mild, 4-point: moderate; 5-point:severe) using the Anti-aging QOL Com- mon Questionnaire (AA-QOL) [
The symptomatic evaluated items are 30 physical symptoms and 21 mental ones. The physical symptoms are listed as “tired eyes”, “blurry eyes”, “eye pain”, “stiff shoulders”, “muscular pain/stiffness”, “palpitations”, “dyspnea”, “tendency to gain weight”, “weight loss; thin”, “lethargy”, “no feeling of good health”, “thirst”, “skin problems”, “anorexia”, “early satiety”, “epigastralgia”, “liable to catch colds”, “coughing and sputum”, “diarrhea’, “constipation”, “headaches”, “dizziness”, “tinnitus”, “lumbago”, “arthralgia”, “edematous”, “easily breaking into a sweat”, “frequent urination”, “hot flash”, and “cold skin”. Mental symptoms are listed as “irritability”, “easily angered”, “loss of motivation”, “no feeling of happiness”, “nothing to look forward in life”, “daily life is not enjoyable”, “loss of confidence”, “reluctance to talk with others”, “depressed”, “a sense of uselessness”, “shallow sleep”, “difficulty falling asleep”, “pessimism”, “lapse of memory”, “inability of concentrate”, “inability to solve problems”, “inability to readily make judgements”, “inability to sleep because of worries”, “a sense of tension”, “feeling of anxiety for no special reason”, and “a vague feeling of fear”. The physical symptoms and mental symptoms were evaluated using a five-point scale (1 through 5).
To perform the second evaluation of the QOL scores using the five-point scale, we evaluated the transition of the QOL scores regarding each symptom before and after chemotherapy. We determined a significant change in the second evaluation of the QOL score, when the values changed more than 10% from the baseline score. We allocated the changed rates of each symptom before and after chemotherapy, i.e., as three types, that is improved (“↑”; increased more than 10%), unchanged (“→”; changed within ±10%), and worse (“↓”; decreased less than −10%).
A statistical analysis of the results was performed using the paired t-test. A value of p < 0.05 was considered to indicate a statistically significant change. A statistical analysis of the results was performed using the paired t-test for comparison of the values between the level at the baseline and that after 8 weeks of administration in each group.
A total of 19 patients (13 males and 6 females) received chemotherapy in our department as summarized in
A total of 57 chemotherapy cycles of the planned 2 (n = 8), 3 (n = 3), and 4 cycles (n = 8) were administered as listed in
Regarding the final effect of treatment, that is neo adjuvant therapy (n = 3) and intensive chemotherapy for recurring cases (n = 5), there were 3 partial responses for an overall response rate of 37.5% (3/8) as listed in
Toxicity | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 3/4 (%) | |
---|---|---|---|---|---|---|
Leukopenia | 8 | 5 | 0 | 0 | 0 | |
Neutropenia | 3 | 3 | 5 | 7 | 12 | (63.2) |
Anemia | 3 | 4 | 0 | 0 | 0 | |
Thrombocytopenia | 0 | 3 | 6 | 3 | 9 | (47.4) |
Febrile neutropenia | 0 | 0 | 5 | 0 | 5 | (26.3) |
Toxicity | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
---|---|---|---|---|
Nausea | 16 | 0 | 0 | 0 |
Vomiting | 1 | 0 | 0 | 0 |
Anorexia | 13 | 2 | 0 | 0 |
Fatigue | 13 | 2 | 0 | 0 |
Diarrhea | 2 | 0 | 0 | 0 |
Constipation | 2 | 0 | 0 | 0 |
ALT/AST | 0 | 0 | 0 | 0 |
Creatinine | 0 | 0 | 0 | 0 |
Neuropathy | 0 | 0 | 0 | 0 |
Pain, joint | 1 | 0 | 0 | 0 |
Pain, muscle | 1 | 0 | 0 | 0 |
Skin rash | 1 | 0 | 0 | 0 |
Alopecia | 1 | 5 | 0 | 0 |
Infection | 0 | 0 | 0 | 0 |
Fever | 5 | 1 | 0 | 0 |
Others (hearing) | 0 | 1 | 0 | 0 |
Scale | Items* | Pre-chemotherapy | Post-chemotherapy | p value |
---|---|---|---|---|
(Scores at baseline) | (Scores at 2 weeks) | |||
Daily-life activities | 1 - 6 | 25.3 ± 5.1 | 20.7 ± 6.8 | 0.013 |
Physical condition | 7 - 11 | 21.5 ± 3.2 | 16.4 ± 4.5 | < 0.001 |
Psychological condition | 12 - 16 | 18.6 ± 4.1 | 16.8 ± 4.3 | 0.091 |
Social attitude | 17 - 21 | 13.9 ± 3.8 | 13.2 ± 5.0 | 0.306 |
Face scale | 22 | 3.8 ± 0.9 | 2.9 ± 0.9 | 0.003 |
Overall QOL | 83.1 ± 12.1 | 69.9 ± 17.2 | 0.005 |
*Numbers correspond to item numbers on the 22-item questionnaire (QOL-ACD).
“physical condition” significantly decreased, which changed from 21.5 ± 3.2 at the baseline to 16.4 ± 4.5 at post-chemotherapy (p < 0.001). The scale of “face scale” significantly became worse, which changed from 3.8 ± 0.9 at the baseline to 2.9 ± 0.9 at post-chemotherapy (p = 0.003). The scale of “overall QOL” significantly showed a worse change, which changed from 83.1 ± 12.1 at the baseline to 69.9 ± 17.2 at post-chemotherapy (p = 0.005). For the other scales of “psychology condition” and “social attitude”, the values at post-chemotherapy appeared to undergo a similar change compared to the values at the baseline, however, there were no significant changes.
The symptom of “lethargy” changed from 2.2 ± 1.1 at pre-chemotherapy (at the baseline) to 3.2 ± 1.2 at post-chemotherapy (p = 0.004) (an increase of 1.5- fold magnitude). The symptom of “thirst” changed from 1.7 ± 0.8 at the baseline to 2.5 ± 1.2 at post-chemotherapy (p = 0.006) (an increase of 1.5-fold magnitude). The symptom of “anorexia” changed from 2.1 ± 1.0 at the baseline to 3.5 ± 1.4 at post-chemotherapy (p = 0.001) (increase of 1.7-fold magnitude). The symptom of “early satiety” changed from 1.6 ± 0.8 at the baseline to 2.6 ± 1.3 at post-chemotherapy (p = 0.001) (increase of 1.6-fold magnitude). The symptom of “liable to catch colds” changed from 1.8 ± 0.9 at the baseline to 2.3 ± 1.2 at post-chemotherapy (p = 0.035) (increase of 1.3-fold magnitude). The symptom of “diarrhea” changed from 1.5 ± 0.9 at the baseline to 2.1 ± 1.4 at post-chemo- therapy (p = 0.049) (increase of 1.4-fold magnitude). The symptom of “constipation” changed from 2.2 ± 1.3 at the baseline to 3.2 ± 1.4 at post-chemotherapy (p = 0.005) (increase of 1.5-fold magnitude). Regarding the second evaluation of the anti-aging QOL, 19 items were evaluated and became worse (63.3%, 19/30). These symptoms become worse due to the chemotherapy, while the other 11 items were evaluated to be unchanged (36.7%, 11/30). There were no symptoms that became better after the chemotherapy.
Physical symptoms (30 items) | Post-chemotherapy | p value | change | 2nd evaluation of QOL | |
---|---|---|---|---|---|
(Scores at 2 weeks) | (%) | ||||
Tired eyes | 2.3 ± 1.1 | 2.7 ± 1.2 | 0.131 | 16.1 | ↑ |
Blurry eyes | 2.2 ± 1.0 | 2.3 ± 1.2 | 0.346 | 5.8 | → |
Eye pain | 1.3 ± 0.6 | 1.5 ± 0.8 | 0.145 | 16.1 | ↑ |
Stiff shoulders | 2.5 ± 1.1 | 2.6 ± 1.2 | 0.353 | 4.8 | → |
Muscular pain/stiffness | 2.0 ± 1.1 | 2.5 ± 1.3 | 0.079 | 24.5 | ↑ |
Palpitations | 1.6 ± 0.7 | 1.7 ± 0.8 | 0.353 | 5.1 | → |
Dyspnea | 1.9 ± 1.0 | 2.1 ± 1.1 | 0.247 | 11.1 | ↑ |
Tendency to gain weight | 1.7 ± 1.0 | 1.7 ± 1.0 | 0.483 | −0.7 | → |
Weight loss; thin | 2.3 ± 1.1 | 2.6 ± 1.4 | 0.163 | 15.8 | ↑ |
Lethargy | 2.2 ± 1.1 | 3.2 ± 1.2 | 0.004 | 41.4 | ↑ |
No feeling of good health | 2.5 ± 1.1 | 3.0 ± 1.4 | 0.105 | 18.0 | ↑ |
Thirst | 1.7 ± 0.8 | 2.5 ± 1.2 | 0.006 | 43.9 | ↑ |
Skin problems | 2.1 ± 1.0 | 2.6 ± 1.3 | 0.061 | 26.0 | ↑ |
Anorexia | 2.1 ± 1.0 | 3.5 ± 1.4 | 0.001 | 67.0 | ↑ |
Early satiety | 1.6 ± 0.8 | 2.6 ± 1.3 | 0.001 | 65.8 | ↑ |
Epigastralgia | 1.6 ± 0.7 | 2.0 ± 1.1 | 0.083 | 23.1 | ↑ |
Liable to catch colds | 1.8 ± 0.9 | 2.3 ± 1.2 | 0.035 | 31.0 | ↑ |
Coughing and sputum | 2.5 ± 1.2 | 2.7 ± 1.0 | 0.307 | 6.3 | → |
Diarrhea | 1.5 ± 0.9 | 2.1 ± 1.4 | 0.049 | 38.9 | ↑ |
Constipation | 2.2 ± 1.3 | 3.2 ± 1.4 | 0.005 | 48.1 | ↑ |
Headaches | 2.7 ± 1.4 | 2.7 ± 1.4 | 0.500 | 0.0 | → |
Dizziness | 2.0 ± 1.4 | 2.0 ± 1.4 | 0.500 | 0.0 | → |
Tinnitus | 1.9 ± 0.9 | 2.1 ± 1.0 | 0.188 | 13.3 | ↑ |
Lumbago | 1.7 ± 1.0 | 1.8 ± 1.0 | 0.280 | 10.0 | ↑ |
Arthralgia | 2.0 ± 1.2 | 2.1 ± 1.0 | 0.450 | 2.0 | → |
Edematous | 2.0 ± 1.1 | 2.6 ± 1.3 | 0.063 | 25.5 | ↑ |
Easily breaking into a sweat | 1.7 ± 0.7 | 2.1 ± 1.3 | 0.114 | 21.1 | ↑ |
Frequent urination | 1.5 ± 0.7 | 1.4 ± 0.5 | 0.311 | −5.7 | → |
Hot flash | 2.5 ± 1.4 | 2.4 ± 1.3 | 0.337 | −6.3 | → |
Cold skin | 1.9 ± 0.7 | 2.0 ± 0.8 | 0.283 | 7.0 | → |
A five-point scale (1-point: absolutely none; 2-point: almost not; 3-point: mild, 4-point: moderate; 5-point: severe). Mean ± SD, Wilcoxo’s signed rank test.
Mental symptoms (21 items) | Pre-chemotherapy | Post-chemotherapy | p value | change | 2nd evaluation of QOL |
---|---|---|---|---|---|
(Scores at baseline) | (Scores at 2 weeks) | (%) | |||
Irritability | 1.4 ± 0.5 | 1.5 ± 0.6 | 0.299 | 6.1 | → |
Easily angered | 1.9 ± 1.1 | 1.8 ± 1.2 | 0.402 | −4.3 | → |
Loss of motivation | 2.0 ± 0.8 | 2.3 ± 1.0 | 0.193 | 11.4 | ↑ |
No feeling of happiness | 2.0 ± 0.9 | 2.1 ± 0.9 | 0.367 | 4.5 | → |
Nothing to look forward in life | 2.1 ± 0.8 | 2.6 ± 1.2 | 0.049 | 23.3 | ↑ |
Daily life is not enjoyable | 2.1 ± 1.0 | 2.5 ± 1.2 | 0.089 | 21.2 | ↑ |
Loss of confidence | 1.8 ± 0.9 | 2.2 ± 1.1 | 0.102 | 20.5 | ↑ |
Reluctance to talk with others | 2.0 ± 1.0 | 2.2 ± 1.3 | 0.218 | 13.1 | ↑ |
Depressed | 2.1 ± 1.0 | 2.3 ± 1.1 | 0.222 | 10.7 | ↑ |
A sense of uselessness | 1.9 ± 0.9 | 2.4 ± 1.2 | 0.038 | 29.9 | ↑ |
Shallow sleep | 1.8 ± 0.7 | 2.4 ± 1.3 | 0.031 | 31.9 | ↑ |
Difficulty falling asleep | 2.2 ± 1.0 | 2.4 ± 1.0 | 0.254 | 8.7 | → |
Pessimism | 2.3 ± 1.1 | 2.7 ± 1.2 | 0.101 | 18.1 | ↑ |
Lapse of memory | 2.3 ± 1.1 | 2.7 ± 1.2 | 0.097 | 19.0 | ↑ |
Inability of concentrate | 1.8 ± 0.9 | 2.2 ± 1.2 | 0.104 | 20.8 | ↑ |
Inability to solve problems | 2.4 ± 1.2 | 2.2 ± 1.0 | 0.325 | −6.0 | → |
Inability to make judgements readily | 2.1 ± 0.9 | 2.5 ± 1.2 | 0.098 | 18.7 | ↑ |
Inability to sleep because of worries | 2.1 ± 1.1 | 2.1 ± 0.8 | 0.495 | 0.2 | → |
A sense of tension | 2.0 ± 0.9 | 2.2 ± 1.0 | 0.327 | 6.4 | → |
Feeling of anxiety for no special reason | 2.3 ± 1.1 | 2.5 ± 1.1 | 0.339 | 5.8 | → |
A vague feeling of fear | 2.4 ± 0.9 | 2.3 ± 1.1 | 0.404 | -3.0 | → |
A five-point scale (1-point: absolutely none; 2-point: almost not; 3-point: mild, 4-point: moderate; 5-point: severe), Mean ± SD, Wilcoxo’s signed rank test.
0.049) (increase of 1.2-fold magnitude). The symptom of “a sense of uselessness” changed from1.9 ± 0.9 at the baseline to 2.4 ± 1.2 at post-chemotherapy (p = 0.038) (increase of 1.3-fold magnitude). The symptom of “shallow sleep” changed from 1.8 ± 0.7 at the baseline to 2.4 ± 1.3 at post-chemotherapy (p = 0.031) (increase of 1.3-fold magnitude). Regarding the second evaluation of the anti-aging QOL, 12 items were evaluated that became worse (57.1%, 12/21), and 9 items were evaluated to be unchanged (42.9%, 9/21). There was no symptoms that became better after the chemotherapy.
NSCLC is the leading cause of cancer mortality [
In contrast, adjuvant therapy for early-stage NSCLC has been the focus of many studies in the hope of reducing the relapse risk and improving survival from the 40% to 60% achieved with surgery alone [
In 2010, the NSCLC Meta-analysis Collaborative Group [
The evidence reports about the carboplatin plus gemcitabine regimen in Japan are few compared to those of carboplatin plus paclitaxel, almost all being reported from overseas [
We previously reported the result of chemotherapy (gemcitabine plus carboplatin versus paclitaxel plus carboplatin) in elderly patients with non-small cell lung cancer [
The past decade has seen a significant interest in QOL research within oncology and palliative medicine. It is now widely accepted that some consideration of a patient’s QOL must be an integral part of the optimal medical care. More recently, the term PROs or patient-reported outcome measurement (PROM) was introduced by regulatory authorities [
The outcomes of a clinical intervention obtained by the patient, i.e., PROs, seemed to be of more importance in the future than any other outcomes like the clinical, physiological or caregiver-reported [
The outcomes are broadly classified into clinical (e.g., cure, survival), humanistic (e.g., role performance, emotional status) and economical (e.g., expenses, savings) [
In the present study, we did not use the famous and most world-widely-used EORTC QLQ questionnaire survey, however, we used the two patient-reported questionnaire surveys of the QOL. One is the quality of life questionnaire for cancer patients treated with anticancer drugs (QOL-ACD), which consists of four domains (functional, physical, mental, and psychosocial) and a global face scale, which was developed as a generic questionnaire for Japanese cancer patients undergoing chemotherapy [
Based on the outcomes of the QOL-ACD, the three items (“physical condition”, “social attitude”, and “overall QOL”) at post-chemotherapy significantly showed worse results compared to the values at pre-chemotherapy (at the baseline). For the other scales of “daily-life activities”, “psychology condition”, and “social attitude”, the values at post-chemotherapy became worse compared to the values at the baseline, however, there was no significant changes. For the outcomes of AA-QOL, 4 items of physical symptoms (“thirst”, “anorexia”, “early satiety”, and “diarrhea”) were significantly worse compared to that of baseline. For the second evaluation of AA-QOL, 19 items were observed with increased changes (63.3%, 19/30), while 11 items were unchanged (36.7%, 11/30). For the mental symptoms, 2 items (nothing to look forward in life and a sense of uselessness) were significantly worse compared to those at the baseline. For the second analysis of AA-QOL, 12 items were observed with increased changes (57.1%, 12/21), while 9 items were unchanged (42.9%, 9/21).Based on the outcomes on the symptomatic changes of the QOL after chemotherapy, both the physical and mental symptoms became worse during the chemotherapy term.
Regarding the relationship between the self-reported outcomes based on the questionnaires (QOL-ACD and AA-QOL) and clinical ones used for our four chemotherapeitc regimens, the hematological toxicities showed moderate to severe toxicities(grade 3/4 toxicities were highly observed (14/1, 73.7%). However, in contrast, the non-hematological ones mostly displayed mild toxicities (grade 1/2 toxicities were highly observed). For the mild non-hematological toxicities, the adverse event could not be correctly expressed by the patient’s individual sense and its degrees were a small difference in the QOL, because they were mostly ambiguous and diverse. On the other hand, the self-reported outcomes should be able to express subtle individual sense and changes in the QOL, and its physical and mental symptoms should be able to be accurately indicated as a variable of the QOL change, which information should be useful in the multidisciplinary.
Previously, we reported the PRO of the surgery of lung cancer by the evaluation based on the questionnaires of AA-QOL and EORTC-C30 QLQ [
Based on the research of the difference between the symptoms and HR-QOL [
To clarify the healthy changes of the QOL reported by a patient in chemotherapy due to lung cancers is very important for doctors and nurses, which should play a role in providing the appropriate care and treatment in order to realize a satisfaction by the patients and their support. For a patient receiving chemotherapy due to lung cancer, and for multidisciplinary teamwork, the PROs should provide very helpful information and very convenient to obtain informed consent in making a decision of receiving chemotherapy, which encourages future chemotherapeuic patients to use as a reference in considering the symptomatic and healthy changes during chemotherapeuic treatment.
To clarify the changes of the QOL in chemotherapy reported by a patient with lung cancers is very important for multidisciplinary teamwork, which should play a role in providing the appropriate care and treatment in order to realize a satisfactory patient-support.
Ayabe, T., Tomita, M., Asada, T., Tsuchiya, K., Nemoto, M. and Nakamura, K. (2017) Patient-Reported Outcomes of Chemotherapy Involving Non- Small Cell Lung Cancer: Evaluation by Questionnaires of Quality of Life Regarding Anti-Aging and Anti-Cancer Drugs. Ad- vances in Lung Cancer, 6, 13-35. https://doi.org/10.4236/alc.2017.62002
GEM: Gemcitabine, CBDCA: Carboplatin, PTX: Paclitaxel, CDDP: Cisplatin, DOC: Docetaxel, QOL-ACD: the quality of life questionnaire for cancer patients treated with anticancer drugs, Anti-aging quality of life assessment: AA-QOL.
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