이전에 치료받지 않은 소아청소년 횡문근육종 (Rhabdomyosarcoma)- 항암요법, 항암화학요법, 항암 약물치료 연세암병원 소아혈액종양과 역 (출처 NCI)

[한정우]

항암요법 옵션Chemotherapy Treatment Options

모든 횡문근육종 환아들은 항암화학요법을 받아야만한다. 항암요법의 강도와 기간은 위험군 배정에 따른다. [113] 횡문근육종 치료를 하는 청소년들은 어린 환아들에 비하여 더 적은 혈액학적 독성과 더 많은 말초신경 독성을 갖는다.[114]

저위험군

표준 치료 옵션

저위험군 환자들은 국한된 (비전이성) 배아조직형을 갖고, 예후양호 위치에 존재하는 종양을 갖는다. 이 종양들은 육안적으로 절제된 상태이다 (그룹 I또는 II). 완전히 절제되지 않은 (그룹 III) 안와 부위 배아조직형 종양과, 육안적으로 완전히 절제된 (그룹I또는 II) 예후불량위치 국한 종양이 해당된다. See Table 3 in the Stage Information section of this summary.

저위험군의 특정 하위그룹은 vincristine, actinomycin (VA)로 이루어진2제 항암요법과 잔존 종양에 대한 방사선치료로 치료하였을 때 90% 이상의 생존률을 얻을 수 있다. See Table 6 below.

Table 6. Characteristics of Low-Risk Patients with High Survival Rates Using Two-Drug Therapy with Vincristine and Dactinomycin With or Without Radiation Therapy (Subset A)

Site	Size	Group	Nodes
N0 = absence of nodal spread.
Favorable	Any	I, IIA	N0
Orbital	Any	I, II, III	N0
Unfavorable	≤5 cm	I	N0

The COG-D9602 연구는 388명의 저위험군 배아조직형 횡문근육종을 2개의 군으로 나누었다.

.[115] 하위그룹에 대한 치료 (n = 264; Stage 1 Group I/IIA, Stage 2 Group I, and Stage 1 Group III orbit) 은 VA와 함께 방사선 치료를 하거나 하지 않는 방식으로 48주간 치료하였다. 하위그룹 B (n = 78; Stage 1 Group IIB/C, Stage I Group III nonorbit, Stage 2 Group II, and Stage 3 Group I/II disease) 는 VAC 를 받는다. (total cumulative dose of 28.6 g/m2). 방사선 용량은 Stage 1 group IIA 환자에게는 41.4Gy 를 36Gy로 감량했고, group III 안와종양 환자에게는 50~59Gy를 45Gy로 감량 하였다. 하위그룹 A 환자에서는 5년 전체 FFS가 89%, OS가 97% 였다. 하위그룹 B는 5년 FFS가 85%, OS는 93%였다.

다른 저위험군 하위 그룹 환자들은 VAC 3제 요법 (전체 cyclophosphamide 용량 28.6g/m2)와 잔존종양 부위 방사선 치료 병합으로 최소 90%의 생존률을 얻었다. See Table 7 below.

Table 7. Characteristics of Low-Risk Patients with High Survival Rates Using Three-Drug Therapy with Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy (Subset B)

Site	Size	Group	Nodes
N0 = absence of nodal spread; N1 = presence of regional nodal spread beyond the primary site.
Favorable (orbital or non-orbital)	Any	IIB, IIC, III	N0, N1
Unfavorable	≤5 cm	II	N0
Unfavorable	>5 cm	I, II	N0, N1

COG-ARST0331 임상시험에서는 271례의 새로 진단된 저위험군 환자들을 치료하였다. Stage 1 또는 2 종양 환자로, Group I 또는 II 배아조직형 종양, stage I, group III 안와 배아조직형 종양등이 해당한다. 더 짧은 기간의 항암요법으로, 4 회의 VAC항암요법과 10주간의 VA항암요법으로, 3년 FFS 89%, OS 98%를 나타내었다. 따라서 더 짧은 기간의 치료는 이들 환자에서 치료 성적을 악화 시키지 않는 것 같다.

.[116]

중간위험군 환자Intermediate-risk patients

표준 치료 방법 Standard treatment options

·         IRS-IV 에서 중간위험군 환자들은 3년 생존률이 84%에서 88% 였다. 이 카테고리는 예후불량 위치의 배아조직형 횡문근육종으로 stage 2 와 3에 해당하고, 육안적 잔존 종양이 남은 경우 (group III), 그리고 비전이성 포상조직형 횡문근육종 stage 2 와 3로, 위치에 상관없이 group I, II, III을 모두 포함한다. IRS IV에서 중간위험군 환자들은 표준 VAC 치료 또는 ifosfamide를 alkylating agent로서 사용한 2개의 다른 항암요법 중 하나를 받는 무작위 배정을 받았다. VAC의 치료 성적은 다른 두개의 치료법과 동등하게 좋았고, 치료약제를 사용하기에는 더 편했다. 세가지 치료법 간에 성적의 차이가 없었기 때문에 중간위험군 횡문근육종 환아에서 VAC는 표준 항암화학요법으로 확정되었다. [26]

IRS-IV로 치료 받은 배아조직형 종양 환자들 (더 높은 용량의 알킬화 약제로 치료 받은)은 IRS-III로 치료 받은 (더 적은 알킬화 약제 용량으로 치료받은) 환자들에 비교하였을 때 특정 그룹의 중간위험군 환자에서는 더 높은 용량의 cyclophosphamide를 투여받았을 때 유효성이 더 컸다. 이들 환자들은, 예후양호위치에 발생하고 림프절 전이 양성인 종양 환자, 육안적 잔존 종양이 남은 환자, 예후불량위치 종양으로, 윤악적인 완전 절제를 받은 환자들이며, 단, 예후 불량위치에 발생하였으며 완전 절제 되지 못한 배아조직형 횡문근육종인 경우는 해당하지 않는다. [117] 중간위험군 환자들의 다른 그룹에 대해서는 cyclophosphamide의 강화가 치료 가능하였지만 성적을 향상 시키지는 못하였다.[118]

·         COG는 또한 topotecan과 cyclophosphamide의 추가가 표준 VAC요법에 추가되었을 때 생존률이 증가하는지를 평가하였다. Topotecan은 횡문근육종 xenograft 모델에서 전임상 실험실 결과의 활성에 기초하여 선택 되었고, 이전에 치료 받지 않은 횡문근육종 환아에서 단일 약제로 치료하였을 때 특히 포상조직형 횡문근육종을 가진 환자에서 효과가 있었기 때문에 선택 되었다. .[119,120] 더욱이, cyclophosphamide와 topotecan의 조합은 재방 환자들에서 그리고, 새로 진단된 전이성 환자들에서 상당한 활성도를 보였다. 121,122]  COG-D9803임상시험에서 중간위험군 환자들을 무작위로 VAC치료 또는 VAC와 topotecan/cyclophosphamide 추가 항암요법 군으로 나누어 치료하였다. Topotecan/cyclophosphamide 를 받은 환자들은 VAC 단독 치료를 받은 환자들에 비해 성적이 더 좋은 것은 아니었다. 4년 FFA는 73% (VAC) 및 68% (VAC/VTC) 였다. [121][Level of evidence: 1iiA] 그리하여 VAC는 중간위험군 환자들에서 여전히 표준 선택이다.

·         제한된 기관의 파일럿 연구에서, vincristine/doxorubicin/cyclophosphamide (VDC) alternating with ifosfamide/etoposide (IE) 조합은 중간위험군 횡문근육종 환자 치료에 사용되었다. 이 방식과 표준 치료법의 비교 효능은 더 많은 연구를 필요로 한다.[123][Level of evidence: 3iiiA]

·         대략 20%의 group III 환자들이 치료 완료 당시에 잔존 종괴를 갖게 된다. 잔존 종괴의 존재는 나쁜 예후적 의미를 갖지 않는다.[124,125] 잔존 종괴에 대한 공격적인 대안적 치료는, 계획된 치료를 완료하였을 때 필요하지 않을 수 있다. Group III환자에 있어서 최초 항암요법에 가장 좋은 반응을 보인 정도 (best response)는 전체 생존 결과에 영향을 주지 않았다..[125] 관해항암요법이 대개 9~12주간 시행되는 반면 2.2%의 중간위험군 환자들은 IRS-IV나 COG-D9803으로 치료 받을 때 조기 질병 진행을 보였고 계획된 방사선 치료를 받지 않았다..[126] COG 연구자들은 현재 중간위험군 환자들에서 방사선 치료를 조기에 시행하는 방식에 대한 가치에 대해 연구 하고 있다..

·         457명의 불완전 절제 배아조직형, 포상조직형 횡문근육종, 미분화 육종, 또는 연부조직 PNET을 가진 환자들에 대한 유럽 임상 시험 (SIOP-MMT-95)에서 carboplatin, epirubicin, and etoposide를 표준 치료인 IVA (ifosfamide, vincristine, and dactinomycin (IVA)에 병합하는 것은 생존률을 상승 시키지 못하였다 (3-year OS for IVA was 82%; 3-year OS for IVA plus carboplatin, epirubicin, and etoposide was 80%).[127]

고위험군 High-risk patients

표준 치료 옵션 Standard treatment options

·         고위험군 환자들은 진단 당시에 1개 또는 그 이상의 전이성 질환을 가진다 (Stage IV). 이들 환자들은 계속해서 비교적 나쁜 예후를 보여왔고 (5-year survival rate of 50% or lower) 따라서 새로운 치료 방침이 예후를 개선하는데 필요하다.[112,128,129] 2개의 후향적 연구가 폐에 국한된 전이를 가진 환자들에서 시행되었고 이 요약의 Metastatic sites  에 요약되어 있다.;[111,112]

·         778례의 고위험군 횡문근육종을 다약제 항암요법 (모든 치료법은 cyclophosphamide나 ifosfamide 를 actinomycin, vincristine과 병합하였고, 추가적인 항암약제를 더하기도 더하지 않기도 함)으로 치료하고 국소 요법 (수술을 하며, 방사선을 하거나 하지 않거나) 을 항암 화학요법 시작 3~5개월 사이에 시행한 경우를 pooled analysis 한 경우, 몇가지 나쁜 예후 인자를 찾아내게 된다. 1세 이하, 10세 이상, 예후불량 원발종양, 뼈 전이, 골수 전이 3~4개의 다른 전이 병소 등이 그것이다. 이 모든 인자를 갖지 않는 경우 3년 EFS는 50%였고, 한 개의 예후인자를 가지면 42%, 2개인 경우 18%, 세개인 경우 12%, 4개인 경우 5% 였다. (P < .0001).[130][Level of evidence: 3iiiA]

전이성 횡문근육종 환아의 표준 전신요법은 VAC 3제이다. 표준 VAC에 추가적인 약제를 더하여 생존률을 높이려는 많은 시도에도 불구하고 (또는 VAC중 하나 또는 그 이상의 약제를 새로운 약제로 대체하려는 시도), 어떠한 항암화합요법도 VAC보다 더 효과적이지 못하였다.

o    IRS-IV 연구에서, 3가지의 약제pair조합을 up-front window에서 연구하였다. 즉 IE, vincristine/melphalan (VM),[131] and ifosfamide/doxorubicin (ID) 이다.[132] 이들 환자들은 up-front window 약제를 투여받은 뒤 VAC를 치료 받고 6, 12주에 평가 받았다. IE와 ID치료를 받은 환자들은 OS가 비교가능한 수준이었고 (31% and 34%, respectively), VM보다 좋았다. (22%).[132] 그러나 북미경험에서 stage IV에 대한 VAC치료결과는 비슷하다.

o    진단당시 전이 종양을 가진 환자들에 대한 2상 window 임상 시험들의 결과에서 topotecan, cyclophsphamide는 활성도를 보여주었지만 이전의 요법들에서 보여준 것과 다른 생존률을 보여주지는 못하였다..[121,122] topotecan을 이전에 치료받지 않은 전이성 횡문근육종 소아, 청소년에서 시행한 up-front window 임상시험도 비슷한 결과를 보였다.[120]

o    Irinotecan and irinotecan with vincristine [133] 역시 up-front windows by the COG-STS에서 시도되었다; 반응률은 irinotecan/vincristine이 irinotecan에 비해 더 좋았지만, 여전히 예비 분석의 생존률에서 이전 경험에 비해 생존률이 향상되지 않았다.[133]

o    프랑스의 연구에서 20명의 전이 종양 환자들이Doxorubicin을 2 course에서 사용하는 window 치료를 받았다. 20명중 12명이 반응을 보였고 4명은 진행성 병변을 나타냈다..[134]

o    the International Society of Pediatric Oncology (SIOP) 연구에서 10세 이상 또는 뼈/골수 전이를 보이는 고위험군 향상을 나타내는 환자들에서 여전히 나쁜 생존률을 보여주었다. 이 연구는 표준 6제 요법 이후 vincristine, doxorubicin, cyclophosphamide (VDC) maintenance 하는 방법 대 single-agent doxorubicin or carboplatin window 후에 sequential high-dose monotherapy courses including cyclophosphamide, etoposide, and carboplatin를 하는 방식을 비교 하였다. 고용량항암요법 군에서 생존률 이득은 보이지 않았다.[135]

대안적 치료Alternative Therapies

·         자가 또는 동종 조혈모세포 이식, 고용량 항암요법이 횡문근 육종 환자들의 소수에서 연구 되어 왔다.[136-138]; [139][Level of evidence: 3iiiA] 이 방식은 새로 진단되거나 재발한 횡문근 육종 환자들의 생존률을 개선시키지 못하여 왔다.[138]

임상연구중인 치료 방법Treatment options under clinical eval‎uation

다음은 국가 그리고/또는 기관의 임상시험의 예이다. Information about ongoing clinical trials is available from the NCI Web site.

·         NCI의 intramural Pediatric Oncology Branch 는 T 세포 재구성 후 수지상세포 및 종양 펩타이드 백신을 투여하는 공고면역요법 연구를 수행하였다. 이 연구는 유전자전위 양성 전이성 또는 재발성 유잉 육종과 포상조직형 횡문근 육종 환자들에서 적은 독성으로 수행 되었다. .[140][Level of evidence: 3iiiA]

Current Clinical Trials

Check for U.S. clinical trials from NCI's list of cancer clinical trials that are now accepting patients withpreviously untreated childhood rhabdomyosarcoma. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

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