Safety and efficacy of liposome doxorubicin in the treatment of soft tissue sarcoma in the elderly

doi:10.3877/cma.j.issn.2096-0263.2023.01.003

Abstract

Abstract:

Objective

To investigate the safety and efficacy of liposomal doxorubicin monotherapy in elderly soft tissue sarcoma.

Methods

From January 2017 to January 2021, the clinical data of all elderly patients with soft tissue sarcoma who received surgical treatment and adjuvant chemotherapy in PLA 960th Hospital were retrospectively analyzed. The patients' gender, age, tumor type, site of disease, limb salvage, adjuvant chemotherapy regimen, adverse reaction of chemotherapy, disease-free survival time, and overall survival time were analyzed. All patients were divided into liposome doxorubicin chemotherapy group and doxorubicin and ifosfamide combined chemotherapy group. The safety and clinical effectiveness of chemotherapy between the two groups were statistically analyzed.

Results

Among the 23 patients, 20 (87.0%) elderly patients with soft tissue sarcoma were included in this study, including 13 males (65.0%) and 7 females (35.0%). The age of onset was 60-72 years old, with an average age of 66.0 years. The pathological types of all patients were highly malignant, and undifferentiated pleomorphic sarcoma was the most common pathological type. There were 7 patients in liposomal doxorubicin single drug chemotherapy group and 13 patients in doxorubicin ifosfamide combined chemotherapy group. The 10 most common adverse reactions of chemotherapy such as nausea, vomiting and leucopenia were counted. Referring to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.3 standard, there were 16 times of grade 1-2 adverse reactions and no grade 3-5 adverse reactions in single drug chemotherapy group. There were 60 times of grade 1-2 adverse reactions, 7 times of grade 3 adverse reactions and 4 times of grade 4 adverse reactions, and no grade 5 adverse reactions in combined chemotherapy group. Statistical analysis between groups showed that the combined chemotherapy group had more chemotherapy complications than the single drug chemotherapy group, and the difference was statistically significant (χ²=8.811, P=0.003), the minimum value of leukocyte after chemotherapy was lower in the combined chemotherapy group, and the difference was statistically significant (F=6.605, P=0.019). The median PFS in the monotherapy group was 12 months. The median PFS in the combined chemotherapy group was 17 months, the median OS in the single drug chemotherapy group did not appear during the follow-up time, and the median OS in the combined chemotherapy group was 35 months. There was no difference between the groups.

Conclusion

Liposomal doxorubicin monotherapy has better safety and similar clinical efficacy to combined chemotherapy in elderly soft tissue sarcoma.

Key words: Soft tissue sarcoma, Aged, Liposome doxorubicin, Single drug chemotherapy, Safety

Kai Zheng, Xiuchun Yu, Ming Xu, Jingming Wang, Qian Chen. Safety and efficacy of liposome doxorubicin in the treatment of soft tissue sarcoma in the elderly[J]. Chinese Journal of Geriatric Orthopaedics and Rehabilitation(Electronic Edition), 2023, 09(01): 11-17.

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Figures/Tables 4

References 25

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序号	年龄（岁）	部位	肿瘤类型	手术方式	化疗方案	预后情况	PFS（月）	OS（月）
1	71	左肩	纤维肉瘤	复发后切除	AI	肺转移死亡	16	29
2	69	右肩	多形性脂肪肉瘤	首次切除	AI	肺转移死亡	15	35
3	69	左大腿	未分化多形性肉瘤	复发后切除	AI	多发转移死亡	10	30
4	68	左大腿	平滑肌肉瘤	复发后截肢	AI	无瘤存活	60	60
5	67	右前臂	滑膜肉瘤	复发后切除	AI	多发转移死亡	6	13
6	63	右大腿	未分化多形性肉瘤	复发后切除	AI	无瘤存活	40	40
7	62	左大腿	平滑肌肉瘤	复发后切除	AI	带瘤存活	9	21
8	61	左腹股沟	未分化多形性肉瘤	复发后切除	AI	多发转移死亡	6	11
9	60	右大腿	组织细胞肉瘤	复发后切除	AI	无瘤存活	52	52
10	69	右大腿	滑膜肉瘤	首次切除	AI	无瘤存活	17	17
11	60	左大腿	未分化多形性肉瘤	首次切除	AI	无瘤存活	16	16
12	68	右腹股沟	未分化多形性肉瘤	首次切除	AI	无瘤存活	16	16
13	60	右小腿	未分化多形性肉瘤	首次切除	AI	无瘤存活	18	18
14	70	左大腿	纤维肉瘤	首次切除	A	无瘤存活	22	22
15	64	右腹股沟	纤维肉瘤	复发后截肢	A	无瘤存活	26	26
16	68	左大腿	未分化多形性肉瘤	复发后切除	A	无瘤存活	15	15
17	68	右大腿	滑膜肉瘤	复发后切除	A	多发转移死亡	8	14
18	69	左肩	未分化多形性肉瘤	复发后切除	A	带瘤存活	12	13
19	70	右大腿	未分化多形性肉瘤	复发后切除	A	带瘤存活	10	14
20	72	左大腿	平滑肌肉瘤	复发后切除	A	多发转移死亡	6	13

序号	年龄（岁）	部位	肿瘤类型	手术方式	化疗方案	预后情况	PFS（月）	OS（月）
1	71	左肩	纤维肉瘤	复发后切除	AI	肺转移死亡	16	29
2	69	右肩	多形性脂肪肉瘤	首次切除	AI	肺转移死亡	15	35
3	69	左大腿	未分化多形性肉瘤	复发后切除	AI	多发转移死亡	10	30
4	68	左大腿	平滑肌肉瘤	复发后截肢	AI	无瘤存活	60	60
5	67	右前臂	滑膜肉瘤	复发后切除	AI	多发转移死亡	6	13
6	63	右大腿	未分化多形性肉瘤	复发后切除	AI	无瘤存活	40	40
7	62	左大腿	平滑肌肉瘤	复发后切除	AI	带瘤存活	9	21
8	61	左腹股沟	未分化多形性肉瘤	复发后切除	AI	多发转移死亡	6	11
9	60	右大腿	组织细胞肉瘤	复发后切除	AI	无瘤存活	52	52
10	69	右大腿	滑膜肉瘤	首次切除	AI	无瘤存活	17	17
11	60	左大腿	未分化多形性肉瘤	首次切除	AI	无瘤存活	16	16
12	68	右腹股沟	未分化多形性肉瘤	首次切除	AI	无瘤存活	16	16
13	60	右小腿	未分化多形性肉瘤	首次切除	AI	无瘤存活	18	18
14	70	左大腿	纤维肉瘤	首次切除	A	无瘤存活	22	22
15	64	右腹股沟	纤维肉瘤	复发后截肢	A	无瘤存活	26	26
16	68	左大腿	未分化多形性肉瘤	复发后切除	A	无瘤存活	15	15
17	68	右大腿	滑膜肉瘤	复发后切除	A	多发转移死亡	8	14
18	69	左肩	未分化多形性肉瘤	复发后切除	A	带瘤存活	12	13
19	70	右大腿	未分化多形性肉瘤	复发后切除	A	带瘤存活	10	14
20	72	左大腿	平滑肌肉瘤	复发后切除	A	多发转移死亡	6	13

组别	例数（%）	年龄（岁，±s）	性别[例（%）]		保肢情况[例（%）]		化疗前合并疾病[例（%）]		需治疗的化疗并发症[例（%）]		化疗后白细胞（×10⁹，±s）	平均随访时间（月）
组别	例数（%）	年龄（岁，±s）	男	女	保肢术	截肢术	存在内科疾病	无内科疾病	发生	未发生	化疗后白细胞（×10⁹，±s）	平均随访时间（月）
AI方案	13（65）	65.2（4.2）	9（69.2）	4（30.8）	12（92.3）	1（7.7）	6（46.2）	7（53.8）	9（69.2）	4（30.8）	2.8（1.1）	27.5
A方案	7（35.0）	67.6（4.2）	4（57.1）	3（42.9）	6（85.7）	1（14.3）	6（85.7）	1（14.3）	0（0）	7（100）	4.4（1.6）	16.7
合计	20（100）	66.0（4.2）	13（65.0）	7（35.0）	18（90.0）	2（10.0）	12（60.0）	8（40.0）	9（45.0）	11（55.0）	3.4（1.4）	23.8
统计值		F=1.527	χ²=0.292		χ²=0.220		χ²=2.967		χ²=8.811		F=6.605	F=3.170
P值		0.232	0.589		0.639		0.085		0.003		0.019	0.092

组别	例数（%）	年龄（岁，±s）	性别[例（%）]		保肢情况[例（%）]		化疗前合并疾病[例（%）]		需治疗的化疗并发症[例（%）]		化疗后白细胞（×10⁹，±s）	平均随访时间（月）
组别	例数（%）	年龄（岁，±s）	男	女	保肢术	截肢术	存在内科疾病	无内科疾病	发生	未发生	化疗后白细胞（×10⁹，±s）	平均随访时间（月）
AI方案	13（65）	65.2（4.2）	9（69.2）	4（30.8）	12（92.3）	1（7.7）	6（46.2）	7（53.8）	9（69.2）	4（30.8）	2.8（1.1）	27.5
A方案	7（35.0）	67.6（4.2）	4（57.1）	3（42.9）	6（85.7）	1（14.3）	6（85.7）	1（14.3）	0（0）	7（100）	4.4（1.6）	16.7
合计	20（100）	66.0（4.2）	13（65.0）	7（35.0）	18（90.0）	2（10.0）	12（60.0）	8（40.0）	9（45.0）	11（55.0）	3.4（1.4）	23.8
统计值		F=1.527	χ²=0.292		χ²=0.220		χ²=2.967		χ²=8.811		F=6.605	F=3.170
P值		0.232	0.589		0.639		0.085		0.003		0.019	0.092

项目	脂质体多柔比星单药组（7例）				多柔比星-异环磷酰胺联合组（13例）
项目	1~2级	3级	4级	5级	1~2级	3级	4级	5级
食欲下降	1	0	0	0	9	1	1	0
恶心	2	0	0	0	8	1	1	0
呕吐	1	0	0	0	5	1	0	0
便秘	2	0	0	0	5	0	0·	0
脱发	0	0	0	0	7	0	0	0
无力	1	0	0	0	6	0	0	0
失眠	4	0	0	0	7	0	0	0
口腔溃疡	1	0	0	0	5	1	1	0
贫血	1	0	0	0	3	2	0	0
白细胞减少	3	0	0	0	5	1	1	0
总计	16	0	0	0	60	7	4	0

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