| 摘要: | 緒論
誘導性化療目前在頭頸部癌症的臨床治療上仍是一個有爭議的治療方式。在此研究中，我們比較先使用Docetaxel（歐洲紫杉醇）或Platinum（鉑）的誘導性化療後再接受同步放化療（Concurrent Chemoradiotherapy, CCRT）與直接接受同步放化療患者之存活率。
研究材料與方法
此研究資料係由衛生福利部健康資料加值應用協作中心(The Collaboration Center of Health Information Application, CCHIA) 所取得，分別有來自中央健康保險署管理的全民健康保險資料庫與國民健康署管理的癌症登記資料庫，串聯此兩大台灣醫療衛生資料庫進行分析。從2002年1月1日至2011年12月31日之頭頸部癌症患者被列入研究對象。追蹤時間從指數日期至2013年12月31日。納入標準為：(1)具有頭頸部癌症（根據疾病分類第九版 [ICD-9-CM]代碼140.0至148.9）；(2)年齡大於20歲；(3)美國癌症聯合委員會（American Joint Committee on Cancer, AJCC）頭頸部癌症臨床分期第三期或第四期（無轉移之局部晚期頭頸部腫瘤）；(4)並已經接受過同步放化療或Platinum誘導性化療後再同步放化療之頭頸部癌症患者。排除條件為：(1)已被診斷患有其他癌症之頭頸部癌症病患者；(2)已有遠處轉移患者；(3)處於AJCC臨床分期的第一期或第二期頭頸部癌症患者；(4)放射線治療前同時接受Platinum併Docetaxel化療患者；(5)未滿20歲患者；(6)性別不明患者；(7)放射線治療期間或之後使用Docetaxel患者；(8)放射線治療前接受誘導性化療超過8週患者；(9)放射線治療前接受過Docetaxel治療患者；(10)接受過Cetuximab（標靶治療藥物）治療患者；(11)完整放射線治療後90天之內接受輔助化療患者；(12)放射線治療劑量小於7,000 cGy患者；(13)放射線治療前接受過頭頸部癌症手術患者；(14)鼻咽癌患者、原位癌患者、肉瘤患者、頭頸部癌症再復發者。此研究資料之總數為30,990位頭頸部癌症患者。
研究結果
總共10,721位第三期及第四期無遠處轉移頭頸部癌症患者被納入研究，追蹤時間為4.18（四分位距，3.25）年。共有7,986例同步放化療患者為分組一，503例Docetaxel誘導性化療患者為分組二，2,232例Platinum誘導性化療患者為分組三。我們使用同步放化療病患作為對照組做死亡風險的分析比較。調整年齡，性別，臨床分期和合併症總死亡後，調整後的危險比（Hazard Ratio, HR）分組二為1.37（95%可信區間[CI]，1.22〜1.53）和分組三為1.44（95% CI，1.36~1.52）。在疾病特異性生存率分析中，頭頸部癌症死亡率調整後的HR分組二為1.29（95%CI，1.14〜1.46）分組三為1.47（95%CI，1.38〜1.56）。
結論
我們的研究顯示頭頸部癌症病患先接受Docetaxel或Platinum誘導性化療後再接受同步放化療與單純直接接受同步放化療病患並無提升存活率，反而導致頭頸部癌症病患增加其他非癌症相關之死亡率及頭頸部癌症相關之死亡風險。
Introduction
To the present, the role of induction chemotherapy has remained a subject of controversy. In this study, we directly compared the survival of patients receiving induction chemotherapy using Docetaxel or Platinum given before concomitant chemoradiotherapy (CCRT) with upfront chemoradiotherapy alone.
Materials and methods
The National Health Insurance claims database and cancer registry databases from The Collaboration Center of Health Information Application in Taiwan were linked for the analysis. Head and neck cancer patients from January 1, 2002 to December 31, 2011 were included in the study. The follow-up duration was from the index day to December 31, 2013. The inclusion criteria were having a head and neck cancer (identified according to the International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes 140.0~148.9), being aged > 20 years, being at American Joint Committee on Cancer (AJCC) clinical cancer stage III or IV (locally advanced head and neck cancers without metastasis), and having undergone induction chemotherapy or platinum-based CCRT. Exclusion criteria were having been diagnosed with cancer before the head and neck cancer was confirmed, having distant metastasis, being at AJCC clinical cancer stages I or II, having platinum and Docetaxel combined use before radiotherapy (RT), being younger than 20 years, one''s gender being unknown, and having Docetaxel use during or after RT, induction chemotherapy beyond 8 weeks before RT, only one course of induction chemotherapy before RT, Cetuximab use, adjuvant chemotherapy within 90 days after completion of RT, <7,000 cGy dose of RT, curative head and neck cancer surgery before RT, nasopharyngeal cancer, carcinoma in situ, a sarcoma, and head and neck cancer recurrence. The total number of enrolled head and neck cancer patients was 30,990 persons.
Results
In total, 10,721 stage III or IV head and neck cancer patients without distant metastasis were included in the study, and the median follow-up duration was 4.18 (interquartile range, 3.25) years. There were 7,968 patients in the CCRT group (arm 1); 503 patients in the induction chemotherapy with Docetaxel group of arm 2, and 2232 patients in the induction chemotherapy with platinum group of arm 3. We used the CCRT arm as the control arm to investigate the risk of death after induction chemotherapy. After adjusting for age, gender, clinical stage, and comorbidities, the adjusted hazard ratios (HRs) of overall deaths were 1.37 (95% confidence interval [CI], 1.22~1.53) in arm 2 and 1.44 (95% CI, 1.36~1.52) in arm 3. In a disease-specific survival rate analysis, the adjusted HRs of head and neck cancers deaths were 1.29 (95% CI, 1.14~1.46) in arm 2 and 1.47 (95% CI, 1.38~1.56) in arm 3.
Conclusions
Our cohort study showed that induction chemotherapy with Docetaxel or Platinum did not improve survival and also resulted in more all-causes death and head and neck cancer death risks compared to CCRT. |
